SURGICAL MESH

Additional Manufacturer Narrative

THIS REPORT IS FOR AN UNKNOWN VERT BODY REPLACE - MESH/UNKNOWN LOT NUMBER. WITHOUT THE SPECIFIC PART NUMBER, THE UDI NUMBER AND 510K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

Description of Event or Problem

THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MICHAEL D. DAUBS (2005), EARLY FAILURES FOLLOWING CERVICAL CORPECTOMY RECONSTRUCTION WITH TITANIUM MESH CAGES AND ANTERIOR PLATING, SPINE VOL. 30 (N12), PAGES 1402-1406 (USA).DOI: 10.1097/01.BRS.0000166526.78058.3C. THE AIM OF THIS RETROSPECTIVE STUDY IS TO EVALUATE THE USE OF TITANIUM MESH CAGES IN THE RECONSTRUCTION OF THE CERVICAL SPINE FOLLOWING CORPECTOMY. A TOTAL OF 23 PATIENTS (13 MALES AND 10 FEMALES) WITH A MEAN AGE OF 61 YEARS (RANGE, 32 TO 84 YEARS) WERE INCLUDED IN THE STUDY. THESE PATIENTS UNDERWENT ANTERIOR CERVICAL CORPECTOMY RECONSTRUCTED WITH A TITANIUM MESH CAGE, LOCAL AUTOGRAFT, AND FIXED ANTERIOR PLATING. HARMS CAGES WERE USED IN 22 PATIENTS AND SYN-MESH IN 1 PATIENT. ALL CASES WERE STABILIZED WITH A FIXED ANTERIOR CERVICAL PLATE. A SYNTHES CSLP PLATE WAS USED IN 22 PATIENTS AND A DEPUY PEAK PLATE IN 1. THE MEAN DURATION OF FOLLOW-UP WAS 28 MONTHS. THE ARTICLE DID NOT SPECIFY WHICH OF THE DEVICES WERE BEING USED TO CAPTURE THE FOLLOWING COMPLICATIONS: A (B)(6)-YEAR-OLD FEMALE PATIENT HAD A CATASTROPHIC FAILURE OF FIXATION WITH CAGE SUBSIDENCE AND DISTAL PLATE EXTRUSION AFTER 8 WEEKS POSTOPERATIVELY. A (B)(6)-YEAR-OLD FEMALE PATIENT HAD A CATASTROPHIC FAILURE OF FIXATION WITH CAGE SUBSIDENCE AND DISTAL PLATE EXTRUSION AFTER 4 WEEKS POSTOPERATIVELY. A (B)(6)-YEAR-OLD MALE PATIENT HAD A CATASTROPHIC FAILURE OF FIXATION WITH CAGE SUBSIDENCE AND DISTAL PLATE EXTRUSION AFTER 2 WEEKS POSTOPERATIVELY. A (B)(6)-YEAR-OLD FEMALE PATIENT HAD A CATASTROPHIC FAILURE OF FIXATION WITH CAGE SUBSIDENCE AND DISTAL PLATE EXTRUSION AFTER 3 WEEKS POSTOPERATIVELY. AN (B)(6)-YEAR-OLD MALE PATIENT HAD A CATASTROPHIC FAILURE OF FIXATION WITH CAGE SUBSIDENCE AND DISTAL PLATE EXTRUSION AFTER 5 WEEKS POSTOPERATIVELY. A (B)(6)-YEAR-OLD MALE PATIENT HAD A FAILURE RECONSTRUCTION AFTER 7 WEEKS POSTOPERATIVELY. 1 PATIENT HAD FIXATION FAILURE IN THE 1-LEVEL CORPECTOMY GROUP. 4 PATIENTS HAD FIXATION FAILURE IN THE 2-LEVEL GROUP. 2 PATIENTS HAD FIXATION FAILURE IN THE 3-LEVEL GROUP. 1 PATIENT WITH A POSTOPERATIVE HEMATOMA REQUIRING SURGICAL EVACUATION. 2 PATIENTS WITH SEVERE DYSPHAGIA. 1 PATIENT REQUIRING THE TEMPORARY PLACEMENT OF A GASTRIC FEEDING TUBE. 1 PATIENT WITH A C-5 NERVE PALSY THAT FULLY RECOVERED AT 6 MONTHS AFTER SURGERY. 1 PATIENT DIED 3 MONTHS FOLLOWING REVISION SURGERY OF MYOCARDIAL INFARCT. THE COMPLAINT INVOLVES 27 DEVICES. DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT WILL BE CAPTURED UNDER 3 SEPARATE COMPLAINTS AS LISTED BELOW: (B)(4) ¿ THIS COMPLAINT WILL INCLUDE 9 DEVICES ¿ 3 VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH , 3 PLATES AND 3 SCREWS. (1ST PC). (B)(4) ¿ THIS COMPLAINT WILL INCLUDE 9 DEVICES ¿ 3 VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH, 3 PLATES, AND 3 SCREWS. (2ND PC). (B)(4) ¿ THIS COMPLAINT WILL INCLUDE 9 DEVICES ¿ 3 VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH, 3 PLATES, AND 3 SCREWS. (3RD PC). THIS IPS CAPTURES THE (B)(6)-YEAR-OLD FEMALE PATIENT HAD A CATASTROPHIC FAILURE OF FIXATION WITH CAGE SUBSIDENCE AND DISTAL PLATE EXTRUSION AFTER 8 WEEKS POSTOPERATIVELY. THIS REPORT IS FOR AN UNKNOWN SYNTHES VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH, AN UNKNOWN SYNTHES SCREWS AND AN UNKNOWN SYNTHES CERVICAL SPINE LOCKING PLATE. THIS REPORT IS 1 OF 9 FOR (B)(4).