UNK - CAGE/SPACERS: CERVIOS
Report
- Report Number
- 8030965-2021-09040
- Event Type
- Injury
- Date Received
- October 27, 2021
- Report Date
- September 30, 2021
- Manufacturer
- SYNTHES GMBH
- Product Code
- OVD
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS FOR AN UNK - CAGE/SPACERS: CERVIOS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. REPORTER IS A J&J REPRESENTATIVE. 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 PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. 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.
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS FOR AN UNK - CAGE/SPACERS: CERVIOS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. REPORTER IS A J&J REPRESENTATIVE. 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 PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. 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.
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. H11 ADDITIONAL NARRATIVE: ADDED: B5, H6 HEALTH EFFECT - CLINICAL CODE. RECAPTURED CODES ON H6. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE CURRENT REPORT IS A RETROSPECTIVE ANALYSIS OF 133 PATIENTS (57 FEMALES AND 76 MALES) WHO UNDERWENT INSTRUMENTATION WITH CERVIOS BETWEEN JANUARY 02, 2006, AND NOVEMBER 22, 2020. IN 1 CASE IT WAS COMBINED WITH SKYLINE. 15 CASES COMBINED WITH ANTERIOR NON-DEPUY DEVICES WERE EXCLUDED, LEAVING 118 CASES FOR ANALYSIS. MEAN AGE OF THE PATIENTS WAS 51 YEARS. REGISTERED INTRA-OPERATIVE COMPLICATIONS: 1 DURAL TEAR, 3 ROOT INJURY, 2 OTHER. REINTERVENTIONS DURING INDEX STAY: 1 ADJUSTMENT IMPLANT. REGISTERED POST-OP COMPLICATIONS WITHIN 1 YEAR: 15 DYSPHAGIA, 10 RECURRENT NERVE INJURY. READMISSIONS: 1 REDECOMPRESSION. 1 SUBSEQUENT REOPERATION AT A NEW INDEX LEVEL. GLOBAL ASSESSMENT OF NECK PAIN (GA) FAILURE % : FU 1 YRS. 49%, FU 2 YRS. 48% FU 5 YRS. 47%. GLOBAL ASSESSMENT OF ARM PAIN (GA) FAILURE % : FU 1 YRS. 40%, FU 2 YRS. 40% FU 5 YRS. 47%. THIS IS FOR DEPUY SYNTHES CERVIOS. THIS REPORT IS FOR ONE (1) UNK - CAGE/SPACERS: CERVIOS. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE CURRENT REPORT IS A RETROSPECTIVE ANALYSIS OF 133 PATIENTS (57 FEMALES AND 76 MALES) WHO UNDERWENT INSTRUMENTATION WITH CERVIOS BETWEEN JANUARY 02, 2006, AND NOVEMBER 22, 2020. IN 1 CASE IT WAS COMBINED WITH SKYLINE. 15 CASES COMBINED WITH ANTERIOR NON-DEPUY DEVICES WERE EXCLUDED, LEAVING 118 CASES FOR ANALYSIS. MEAN AGE OF THE PATIENTS WAS 51 YEARS. REGISTERED INTRA-OPERATIVE COMPLICATIONS: 1 DURAL TEAR, 3 ROOT INJURY, 2 OTHER. REINTERVENTIONS DURING INDEX STAY: 1 ADJUSTMENT IMPLANT. REGISTERED POST-OP COMPLICATIONS WITHIN 1 YEAR: 15 DYSPHAGIA, 10 RECURRENT NERVE INJURY. READMISSIONS: 1 REDECOMPRESSION. 1 SUBSEQUENT REOPERATION AT A NEW INDEX LEVEL. GLOBAL ASSESSMENT OF NECK PAIN (GA) FAILURE % : FU 1 YRS. 49%, FU 2 YRS. 48% FU 5 YRS. 47%. GLOBAL ASSESSMENT OF ARM PAIN (GA) FAILURE % : FU 1 YRS. 40%, FU 2 YRS. 40% FU 5 YRS. 47%. THIS IS FOR DEPUY SYNTHES CERVIOS. THIS REPORT IS FOR ONE (1) UNK - CAGE/SPACERS: CERVIOS. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
HIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA) "DEPUY SPINAL IMPLANTS SUBREPORT 15 ¿ CERVIOS" FOR A TOTAL OF 151 PATIENTS WHO UNDERWENT INSTRUMENTATION WITH CERVIOS BETWEEN (B)(6) 2006 AND (B)(6) 2022. IN 2 CASES IT WAS COMBINED WITH SKYLINE. 15 CASES COMBINED WITH ANTERIOR NON-DEPUY DEVICES WERE EXCLUDED, LEAVING 136 CASES FOR ANALYSIS. MEAN AGE OF THE PATIENTS WAS 51 YEARS. COMPLICATIONS REPORTED IN SWEDISH SPINE REGISTRY (SWESPINE) WERE: REGISTERED INTRA-OPERATIVE COMPLICATIONS (N=5): 1 DURAL TEAR, 1 HEMATOMA, 1 ROOT INJURY, 2 OTHER. REGISTERED POST-OP COMPLICATIONS WITHIN 1 YEAR (N=27): 16 DYSPHAGIA, 11 RECURRENT NERVE INJURY. REOPERATIONS (N=2): 1 ADJUSTMENT IMPLANT, 1 REDECOMPRESSION.
THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA) "DEPUY SPINAL IMPLANTS SUBREPORT 2025 ¿ CERVIOS" FOR A TOTAL OF 183 PATIENTS (153 [48%] WERE FEMALES) WHO UNDERWENT INSTRUMENTATION WITH CERVIOS BETWEEN (B)(6) 2006 AND (B)(6) 2024. IN 4 CASES IT WAS COMBINED WITH A NON-DEPUY CAGE AND 1 CASE WITH CERVIOS CHRONOS. TWO CASES WERE COMBINED WITH CSLP, 2 CASES WITH SKYLINE AND 16 CASES WITH A NON-DEPUY PLATE. THERE WERE NO CASES COMBINED WITH POSTERIOR FIXATION. EXCLUSION OF ALL COMBINED CASES LEAVES 158 STAND-ALONE CASES FOR ANALYSIS. MEAN AGE WAS 50 YEARS. COMPLICATIONS REPORTED IN SWEDISH SPINE REGISTRY (SWESPINE) WERE: REGISTERED INTRA-OPERATIVE COMPLICATIONS (N=5): - 1 DURAL TEAR. - 1 HEMATOMA. - 1 ROOT INJURY. - 2 OTHER. REGISTERED POST-OP COMPLICATIONS WITHIN 1 YEAR (N=33): - 19 DYSPHAGIA. - 14 RECURRENT NERVE INJURY. REOPERATIONS (N=2): - 1 ADJUSTMENT IMPLANT. - 1 REDECOMPRESSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1603661 | UNK - CAGE/SPACERS: CERVIOS | INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR | OVD | SYNTHES GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |