INTEGRATE-C

Description of Event or Problem

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A DISTRIBUTOR REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH AN INTEGRATE-C DEVICE DURING ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C4-7. AFTER INSERTING THE IMPLANT INTO THE DISC SPACE, A PORTION OF THE ANTERIOR THREADED REGION OF THE IMPLANT WAS REPORTED TO REMAIN ATTACHED TO THE THREADED INSERTER HANDLE UPON ITS REMOVAL FROM THE IMPLANT. THE SURGEON ELECTED TO LEAVE THE IMPLANT IN SITU AFTER CAREFUL EVALUATION OF THE IMPLANT PLACEMENT, STABILITY, AND RESTORATION OF DISC HEIGHT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

Additional Manufacturer Narrative

THE EVENT DID NOT RESULT IN ANY PATIENT HARM, INJURY, OR SURGICAL DELAY. NEITHER THE DEVICE NOR THE INTEROPERATIVE PATIENT X-RAY FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, A DEFINITIVE CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. BASED ON THE NARRATIVE PROVIDED BY THE DISTRIBUTOR REPRESENTATIVE PRESENT AT THE TIME OF THE EVENT, THE DEVICE MALFUNCTION MAY HAVE BEEN CAUSED BY A CANTILEVER FORCE APPLIED INTENTIONALLY OR UNINTENTIONALLY TO THE THREADED INSERTER HANDLE WHILE ATTACHED TO THE IMPLANT IN THE C6/7 DISC SPACE. THE SURGEON EVALUATED THE IMPLANTED DEVICE AND OBSERVED NO OTHER MALFUNCTION OF THE IMPLANT OR DETRIMENT TO THE SURGICAL OUTCOME. HAPPE SPINE HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AT THE TIME OF THE SUBMISSION DATE OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.