SCREW,FIXATION,BONE
Report
- Report Number
- 8030965-2018-59081
- Event Type
- Injury
- Date Received
- December 17, 2018
- Report Date
- November 20, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HWC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EVENT : UPDATED EVENT DESCRIPTION AND CONCOMITANT DEVICES REPORTED. THIS REPORT IS FOR AN UNKNOWN MONO/POLYAXIAL SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN PATIENT CODE 3191 USED TO CAPTURE: THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. THE PLATE BROKE POSTOPERATIVELY REQUIRING REVISION SURGERY. THE SCREWS (2) WERE BACKED OUT ON X-RAY. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. INVESTIGATION SUMMARY: X-RAYS REVIEWED BY CQCCHART TEAM. THE FAILURE APPEARS TO BE THE BREAKAGE (PULL-OUT) OF THE SCREW SUB-COMPONENT OF THE T-PLATE. NO FINAL CONCLUSION POSSIBLE AS ONLY ONE X-RAY IN ONE PLANE IN POOR QUALITY IS WAS RECEIVED.THE RISK FILE OF THE SYNAPSE OCCIPITAL SCREWS WAS REVIEWED AND THIS COMPLAINT CONDITION IS ADEQUATELY ADDRESSED. PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED, THEREFORE NO FURTHER EVALUATION IS POSSIBLE. 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. 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. 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.
1/1/2019 UPDATED EVENT DESCRIPTION: DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT HAD BEEN EXPERIENCING A LOT OF PAIN. THE PATIENT HAD IMPLANTATION OF AN OCCIPITO-CERVICAL SYNAPSE PLATE (OC SYNAPSE) DEVICE A COUPLE OF YEARS AGO. THE PATIENT HAD A FALL AND HAS BEEN DETERIORATING. SCANS / RADIOGRAPHS WERE DONE AND FOUND THAT THE OCCIPITO-CERVICAL SYNAPSE PLATE IMPLANT HAD BROKEN IN SITU. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY REPORTED. IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: OCCIPITAL SCREW (PART#04.601.110, LOT#9955386 , QUANTITY#1) OCCIPITAL SCREW (PART#04.601.110, LOT#8636407, QUANTITY#1) OCCIPITAL SCREW (PART#4.601.110, LOT#UNKNOWN, QUANTITY#1) LOCKING CAP (PART#04.614.508, LOT#H682562, QUANTITY#1) LOCKING CAP (PART#04.614.508, LOT#H081462, QUANTITY#1) LOCKING CAP (PART#04.614.508, LOT#UNKNOWN, QUANTITY#2) . THIS IS REPORT 2 OF 2 FOR (B)(4).
IT WAS FURTHER REPORTED THAT REVISION SURGERY WAS COMPLETED AS PLANNED ON (B)(6) 2018. REVISION SURGERY WAS COMPLETED SUCCESSFULLY.
510K: THIS REPORT IS FOR AN UNKNOWN MONO/POLYAXIAL SCREWS: SYNAPSE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). OCCUPATION: INITIAL REPORTER IS SYNTHES SALES CONSULTANT. 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. (B)(4). 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.
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH AN UNKNOWN SYNAPSE OCCIPITAL PLATE ON UNKNOWN DATE, REPORTEDLY A COUPLE OF YEARS AGO. ON UNKNOWN DATE, PATIENT REPORTED PAIN. IT WAS FURTHER REPORTED PATIENT SUFFERED A FALL THAT HAS BEEN DETERIORATING. SCANS AND RADIOGRAPHS WERE CONDUCTED, REVEALING AN OCCIPITAL PLATE WAS BROKEN IN SITU. A REVISION PROCEDURE IS PLANNED BUT HAS NOT YET BEEN SCHEDULED. CONCOMITANT DEVICE REPORTED: SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) UNKNOWN-MONO/POLYAXIAL SCREWS: SYNAPSE. THIS IS REPORT 2 OF 2 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1011753 | SCREW,FIXATION,BONE | HWC | OBERDORF SYNTHES PRODUKTIONS GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |