ABC SELF-LOCKING CERVICAL SCREW 4.0X16MM

Additional Manufacturer Narrative

EXEMPTION NUMBER: E2014018. DATE OF INCIDENT: ((B)(6)). DATE OF PRIMARY SURGERY: UNKNOWN. THERE IS NEITHER A PRODUCT NOR A BATCH KNOWN, A BATCH HISTORY REVIEW IS NOT POSSIBLE. THE ROOT CAUSE FOR PROBLEM IS MOST PROBABLY USAGE RELATED. WITH THE LACK OF INFORMATION AND WITHOUT FURTHER KNOWLEDGE ABOUT THE CIRCUMSTANCES, IT IS ASSUMED, THAT THE SCREW WAS NOT PLACED AND LOCKED PROPERLY. THE IFU POINTS OUT SEVERAL HINTS FOR PROPERLY USAGE OF THE ABC - SELF-LOCKING SCREWS: >DEFICIENT LOCKING OF THE ABC SCREW DUE TO INCOMPLETE ENGAGING IN THE HOLE OF THE ABC PLATE! ENSURE THAT THE ABC SCREW FULLY ENGAGES IN THE HOLE OF THE ABC PLATE. >BACK OUT OF THE ABC SCREW FROM THE ABC PLATE THROUGH CONTACT OF THE SCREW THREAD WITH THE CAGE OR BONE GRAFT! ENSURE THAT THE SCREW THREAD OF THE ABC SCREW IS NOT IN CONTACT WITH THE CAGE OR BONE GRAFT ON INSERTION. A CAPA IS NOT NECESSARY.

Description of Event or Problem

IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL "AFTER SURGERY THE PHYSICIAN DISCOVERED FROM A ROUTINE X-RAY TWO ABC SCREWS BACKED OUT APPROXIMATELY 2CM. THE PATIENT CONDITION HAS CURRENTLY BEEN STABLE AND NO INJURIES REPORTED. REVISION SURGERY HAS NOT BEEN PLANNED. NO INVASIVE MEDICAL INTERVENTION IS SCHEDULED. THE SURGEON PLANS TO MONITOR THE PATIENT CAREFULLY."