ABC

Description of Event or Problem

A CUSTOMER CONTACTED AESCULAP INC. REGARDING THE REMOVAL OF AN ABC CERVICAL PLATE (PART # FJ750T) DURING A PLANNED SURGICAL PROCEDURE. THE DEVICE HAD BEEN PREVIOUSLY IMPLANTED; HOWEVER, THE EXACT IMPLANTATION DATE IS UNKNOWN. FOLLOW-UP WITH THE REPORTER CONFIRMED THAT NO ADVERSE EVENT OCCURRED AND NO DEVICE MALFUNCTION WAS IDENTIFIED. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS RELATED TO THE DEVICE. THE DEVICE REMOVAL WAS PERFORMED AS PART OF ROUTINE AFTERCARE ASSOCIATED WITH A PLANNED SURGICAL PROCEDURE AT AN ADJACENT LEVEL, CONSISTENT WITH THE ORIGINAL SURGICAL PLAN. THE REMOVAL WAS NOT PERFORMED AS A REVISION SURGERY DUE TO DEVICE-RELATED ISSUES OR PATIENT COMPLICATIONS. THE REPORTER NOTED DIFFICULTY IDENTIFYING APPROPRIATE INSTRUMENTS FOR DEVICE REMOVAL AND EXPRESSED CONCERN REGARDING AVAILABLE TOOLING; HOWEVER, THIS DID NOT RESULT IN PATIENT HARM OR DEVICE MALFUNCTION.

Additional Manufacturer Narrative

THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4). INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS (DHR) WERE NOT ABLE TO BE REVIEWED AS NO LOT NUMBER WAS MADE AVAILABLE. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. CONCLUSION AND MEASURES / PREVENTATIVE MEASURES: A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.