English - ulrich medical ADDplus anterior distraction device plus Instructions For Use Manual

SYSTEM: ADDplus™ anterior distraction device plus

ENGLISH

LANGUAGE:
The only version applicable to users in the U.S. is the version intended especially for the United States.
BEFORE CLINICAL USE, TAKE NOTE OF THESE INSTRUCTIONS FOR USE AND THE
!
SYSTEM-RELATED SURGICAL TECHNIQUE!
GENERAL INFORMATION
Please ensure that you are using and observing the most current instructions for use and surgical technique of this system at all times. These
can be downloaded any time free of charge at: www.ifu.ulrichmedical.com
INTENDED USE
The Anterior Distraction Device Plus (ADDplus) is an expandable vertebral body replacement with integrated plates for fixation to the spine
(C3-T3). It is used to bridge the intervertebral space which has developed during the resection of the vertebral body. The implant supports the
anterior spine until the requested spinal profile and the correct intervertebral height is restored.
INDICATIONS
Instabilities of different genesis, such as conditions after complete or incomplete corpectomy due to destruction of a vertebral body by tumor,
fracture or conditions after removal of the disk for degeneration.
CONTRAINDICATIONS
ƒ Patients with acute infection, whether superficial or deep
ƒ Patients with fever or leukocytosis
ƒ Patients with obesity
ƒ Patients with a history of material allergy or who tend to react to foreign bodies
ƒ The physician must consider carefully before treating patients who are in a generally unfavorable medical or psychological state and who
could be made worse by the procedure
ƒ Patients with inadequate bone quality or quantity (e.g. severe osteoporosis, osteopenia, osteomyelitis)
ƒ Pregnancy
SPECIAL WARNING AND APPLICATION INSTRUCTIONS
ƒ The ADDplus is inserted through the anterolateral cervical approach.
ƒ The vertebral body is resected including the neighboring disks.
ƒ The height adjusted after the in-situ expansion is secured by means of a locking screw.
ƒ Subsequently, the plates of the ADDplus are screwed to the neighboring vertebral bodies by means of cancellous bone screws (Ø 4.0 mm)
or osmium screws.
ƒ Inadequate screw anchorage in the vertebral body can lead to instability and loosening of the implant.
ƒ The implant should be used in an anatomically correct position in compliance with currently valid standards for internal fixation.
ƒ Implant failure is possible even after successful fusion. The implant cannot withstand physiological and biomechanical forces over the long
term unless the bones fuse successfully. A prolonged healing phase, unsuccessful bone fusion or subsequent bone resorption or trauma can
place undue stress on the implant, which, in turn, could lead to loosening, deformation, cracks or breakage of the implant.
ƒ A re-contouring of the implant in the area of the plates, in particular, is not permitted. This may lead to damage or breakage of the implant.
ƒ The inserted implant serves to reconstruct substance defects of the surgical site over a maximum two-year healing process. After the
surgical site is fused, the implant is firmly anchored in the bone. The implant is therefore not intended to be removed unless there are
complications, implant failure, or a delayed healing phase (no fusion within 2 years) that require implant removal. The decision to do so
should only be made after a meticulous risk to benefit assessment by a medical specialist.
ƒ After the surgery, it is recommended to wear a neck brace.
This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU. The onus resides with
the user to ensure that the most up-to-date IFU is used.
ulrich GmbH & Co. KG l Buchbrunnenweg 12 l 89081 Ulm l Germany
Phone: +49 (0)731 9654-0 l Fax: +49 (0)731 9654-2705
spine@ulrichmedical.com l www.ulrichmedical.com
7
WS 2295-01-MULI-eIFU
R8/2019-11
2020-03-13