RABEA

Additional Manufacturer Narrative

A CUSTOMER COMPLAINT HAS REVEALED THAT THE FOLLOWING MEDICAL DEVICE: REF: WK041214; RABEA PEEK CERVICAL CAGE ANGLED 4X12X14MM 5°, LOT 818192-KT - CONTAINS ITEM PK041214, RABEA PEEK - CERVICAL CAGE PARALLEL 4X12X14MM 0°. OUR FIRST INVESTIGATIONS REVEALED THAT A WRONG LABELLING OCCURRED IN THE FRAMEWORK OF THE MANUFACTURING PROCESS. ONLY THE PRODUCT MENTIONED ABOVE AND ONLY THAT SINGLE LOT NUMBER IS AFFECTED. IT HAS NOT BEEN DEFINITIVELY DETERMINED HOW MANY PRODUCTS ARE AFFECTED BY THE WRONG LABELLING. THERE IS A RISK THAT PATIENTS WHO WERE TREATED WITH THAT PRODUCT RECEIVED A PARALLEL CERVICAL CAGE WITH A LORDOTIC ANGLE OF 0° INSTEAD OF 5°. THERE IS NO ADDITIONAL HEALTH RISK FOR PATIENTS WHO HAD A PARALLEL CAGE IMPLANTED INSTEAD OF A LORDOTIC CAGE. THE POSITION OF THE CAGE IN RELATION TO THE ADJACENT VERTEBRAL BODIES IS BEING CHECKED DURING THE SURGERY. BASED ON THAT THE SURGEON DECIDES WHETHER THE TREATMENT IS COMPLETED OR WHETHER THERE IS A NECESSITY FOR ADDITIONAL MEASURES, E.G. A STABILIZATION WITH A PLATE. COMPARED TO THE LORDOTIC RABEA CAGE THE PARALLEL CAGE IS APPROX. 1,2 MM HIGHER ON THE POSTERIOR SIDE. THEREFORE IN COMPARISON WITH THE LORDOTIC CAGE NO ADDITIONAL STRAIN ON THE NEURONAL STRUCTURES IS TO BE EXPECTED, ALL THE MORE BECAUSE THE DISTRACTION OF THE VERTEBRAL BODIES REQUIRED FOR THE SURGICAL PROCESS IS REVERSED AFTER THE IMPLANTATION OF THE CAGE. A NEGATIVE EFFECT ON THE BONY FUSION STARTING AFTER THE SURGERY IS NOT TO BE EXPECTED. IN CONSIDERATION OF THE RISK ASSESSMENT AND THE FACT THAT NO NEGATIVE EFFECTS ON THE HEALTH OF THE PATIENTS INVOLVED ARE TO BE EXPECTED NO ADDITIONAL AFTERCARE MEASURES ARE REQUIRED. SIGNUS DOESN'T DEEM IT NECESSARY TO INFORM THE PATIENTS ABOUT THE SITUATION. IT IS AT THE TREATING DOCTOR'S DISCRETION TO INFORM THE PATIENT IF NECESSARY. AFFECTED DEVICES HAVE BEEN DISTRIBUTED IN (B)(6) ONLY.

Description of Event or Problem

A CUSTOMER COMPLAINT HAS REVEALED THAT THE FOLLOWING MEDICAL DEVICE: REF: WK041214; RABEA PEEK CERVICAL CAGE ANGLED 4X12X14MM 5°, LOT 818192-KT - CONTAINS ITEM PK041214, RABEA PEEK - CERVICAL CAGE PARALLEL 4X12X14MM 0°. OUR FIRST INVESTIGATIONS REVEALED THAT A WRONG LABELLING OCCURRED IN THE FRAMEWORK OF THE MANUFACTURING PROCESS. ONLY THE PRODUCT MENTIONED ABOVE AND ONLY THAT SINGLE LOT NUMBER IS AFFECTED. THE DEVICE IN QUESTION WAS NOT DELIVERED TO U.S. MARKET.