UNK - VERTEBRAL BODY REPLACEMENT - TITANIUM MESH

Description of Event or Problem

THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LI, Z. ET AL (2017), COMPARISON OF THREE RECONSTRUCTIVE TECHNIQUES IN THE SURGICAL MANAGEMENT OF PATIENTS WITH FOUR-LEVEL CERVICAL SPONDYLOTIC MYELOPATHY, SPINE, VOL. 42 (10), PAGES E575¿E583 (CHINA). THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE PERIOPERATIVE PARAMETERS, CLINICAL OUTCOMES, RADIOGRAPHIC PARAMETERS, AND COMPLICATION RATES OF THREE RECONSTRUCTIVE TECHNIQUES AFTER THE ANTERIOR DECOMPRESSION OF FOUR-LEVEL CERVICAL SPONDYLOTIC MYELOPATHY (CSM). BETWEEN JULY 2006 AND FEBRUARY 2014, A TOTAL OF 97 PATIENTS (66 MALE AND 31 FEMALE; MEAN AGE OF 55.8 YEARS [RANGE, 38¿72 YR]) WHO UNDERWENT SURGERY FOR FOUR-LEVEL CSM WERE INCLUDED IN THE STUDY. THESE PATIENTS DIVIDED INTO SACCF (N=39; 28 MALE AND 11 FEMALE; MEAN AGE 56.8±8.6 YEARS) GROUP, MACDF (N=31; 21 MALE AND 31 FEMALE; MEAN AGE OF 54.9±8.1 YEARS) GROUP, AND MACDF-CA (N=27; 17 MALE AND 10 FEMALE; MEAN AGE OF 55.3±7.2 YEARS) GROUP. FOR THE MACDF PROCEDURES, PEEK CAGES (DEPUY SPINE, JOHNSON&JOHNSON, NEW BRUNSWICK, NJ) AND ANTERIOR CERVICAL PLATE (SLIM LOC OR SKYLINE, DEPUY SPINE) WERE USED. FOR THE SACCF PROCEDURES, TITANIUM MESH CAGE (DEPUY SPINE) PLUS ANTERIOR CERVICAL PLATE (DEPUY SPINE) WERE USED. FOR THE MACDF-CA PROCEDURES, FIDJI CERVICAL CAGES (ABBOTT SPINE, BORDEAUX, FRANCE) WERE USED. THE FOLLOW-UP PERIOD WAS 39.1±7.5 MONTHS IN SACCF GROUP, 36.2±7.1 MONTHS IN MACDF GROUP, AND 35.3±7.3 MONTHS IN MACDF-CA GROUP. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: AN UNKNOWN NUMBER OF PATIENTS, WHO HAD LOST TO FOLLOW-UP, DIED. SACCF PROCEDURES: 2 PATIENTS EXPERIENCED TRANSIENT NEUROLOGICAL WORSENING IN THE EARLY POSTOPERATIVE PERIOD. MOST OF THE SYMPTOMS RESOLVED 6 MONTHS POSTOPERATIVELY IN THESE PATIENTS. IN 34/39 PATIENTS, SOLID FUSION WAS ACHIEVED. 1 PATIENT HAD EPIDURAL HEMATOMA. 1 PATIENT HAD C5 PALSY. 2 PATIENTS HAD HOARSENESS. 1 PATIENT HAD AXIAL NECK PAIN. 5 PATIENTS HAD DYSPHAGIA. AMONG THESE, 3 PATIENTS HAD TRANSIENT DYSPHAGIA (<3 MONTHS), 2 PATIENT EXPERIENCED MILD DYSPHAGIA LASTING >3 MONTHS AFTER THE SURGERY. ONE PATIENT SUFFERED FROM SEVERE DYSPHAGIA WITH FREQUENT SWALLOWING DIFFICULTIES EATING SOLID FOOD. HE UNDERWENT A SWALLOW EVALUATION THAT REVEALED PARTIAL ASPIRATION OF FOOD. 1 PATIENT HAD GRAFT DISLODGEMENT. 2 PATIENTS HAD SUBSIDENCE. MACDF PROCEDURES: 2 PATIENTS EXPERIENCED TRANSIENT NEUROLOGICAL WORSENING IN THE EARLY POSTOPERATIVE PERIOD. MOST OF THE SYMPTOMS RESOLVED 6 MONTHS POSTOPERATIVELY IN THESE PATIENTS. IN 28/31 PATIENTS, SOLID FUSION WAS ACHIEVED. 1 PATIENT HAD CEREBRAL FLUID LEAKAGE. 2 PATIENTS HAD C5 PALSY. 2 PATIENTS HAD HOARSENESS. 1 PATIENT HAD AXIAL NECK PAIN. 3 PATIENTS HAD DYSPHAGIA. AMONG THESE, 2 PATIENTS HAD TRANSIENT DYSPHAGIA (<3 MONTHS), AND 1 PATIENT EXPERIENCED MILD DYSPHAGIA LASTING >3 MONTHS AFTER THE SURGERY. 1 PATIENT HAD SUBSIDENCE. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE VERTEBRAL BODY REPLACEMENT - TITANIUM MESH. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 5 OF 5 FOR (B)(4).

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11: ADDITIONAL NARRATIVE: G4-510K: THIS REPORT IS FOR AN UNKNOWN VERTEBRAL BODY REPLACEMENT - TITANIUM MESH/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. H6: COMPONENT CODE: G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) USED TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. 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.