ZERO-P VA CAGE LORDOTIC H8 PEEK
Report
- Report Number
- 8030965-2020-04926
- Event Type
- Injury
- Date Received
- July 16, 2020
- Date of Event
- January 1, 2020
- Report Date
- July 2, 2020
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- OVE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
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. 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. H3, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE HISTORY LOT PART: 04.647.128S, LOT: 1L66082, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: SEP 27, 2018, EXPIRY DATE: SEP 01, 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.
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. H3, H6: MEDICAL SAFETY X-RAY REVIEW: THE PROVIDED FLUORO IMAGE WAS REVIEWED AND IT WAS DETERMINED THERE IS NOTHING SIGNIFICANTLY UNUSUAL FOR THE PLATE AND SCREW POSITIONS, THE C5/6 AND C6/7 DISC SPACES ARE HIGHER THAN THE ADJACENT C3/4 AND C4/5. HOWEVER, IT IS DIFFICULT TO DETERMINE THE REASON OF REVISION ONLY BASED ON THIS ONE IMAGE WITHOUT KNOWING PATIENT SYMPTOM OR CONDITION. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT THE TAN PART OF THE IMPLANT HAS SCRATCHES, DEFORMATION AND DISCOLORATION, MOST LIKELY A RESULT OF EXPLANTATION WITH HARD TOOLS. THE PEEK PART OF THE IMPLANT IS DAMAGED/DEFORMED THESE SIGNS POSSIBLY FROM MECHANICAL WORK AS DRILLING/MILLING BY EXPLANTATION. FURTHERMORE, THERE ARE NO VISIBLE SIGNS OF A PRODUCT ISSUE OR DEFECT. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS ITEM WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. NO PRODUCT ISSUE/DEFECT WERE REPORTED OR/AND IDENTIFIED. THE COMPLAINT IS CONFIRMED, BASED ON THE DAMAGE AT THE IMPLANT AFTER EXPLANTATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY 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.
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. REVIEWING ATTACHED PICTURE HAS SHOWN THAT THE PEEK - BODY IS DETACHED FROM THE CAGE AFTER THE EXPLANT. A STATEMENT WAS PROVIDE FOR THE EXPLANT OF ZERO - P; SURGEON WILL EXPLANT A ZERO-P VA WHICH HAS BEEN IMPLANTED AT A DIFFERENT HOSPITAL. REASON FOR EXPLANT: ACCORDING TO SURGEON THIS IMPLANT IS TOO LARGE. 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.
UPDATED CONCOMITANT DEVICES: CERVICAL SPINE SCREW (PART 04.647.834, LOT L223441, QUANTITY 1); CERVICAL SPINE SCREW (PART 04.647.834, LOT L813301, QUANTITY 2); CERVICAL SPINE SCREW (PART 04.647.834, LOT UNKNOWN, QUANTITY 1).
UPDATED EVENT DESCRIPTION: THE PATIENT WAS IMPLANTED WITH SIZE 8 VARIABLE ANGLE ZERO-PROFILE (ZERO-P VA) IMPLANTS WHICH WERE TOO LARGE. THE SURGEON REVISED TO IMPLANT SIZE 4 VARIABLE ANGLE ZERO-PROFILE (ZERO-P VA) IMPLANTS AND COMMENTED THAT THE PATIENT IS NOW IN VERY GOOD CONDITION.
EXACT DATE OF EVENT IS UNKNOWN. THIS REPORT IS FOR AN UNKNOWN ZERO-P VA IMPLANT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K 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. 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. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT THE TWO (2) VARIABLE ANGLE ZERO-PROFILE (ZERO-P VA) IMPLANTS REMOVAL PROCEDURE ON (B)(6) 2020 DUE TO TOO LARGE IMPLANTS. DEVICES WERE IMPLANTED IN (B)(6) 2020. PATIENT WAS REVISED WITH TWO (2) MEDTRONIC CORNERSTONE IMPLANTS WITH HALF OF THE HEIGHT OF THE FIRST IMPLANTS. PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: ZERO-P VA SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) UNKNOWN ZERO-P VA IMPLANT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745426 | ZERO-P VA CAGE LORDOTIC H8 PEEK | INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL | OVE | OBERDORF SYNTHES PRODUKTIONS GMBH | 1L66082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention | CERVIC-SPINE-SCR Ø3.7 SELF-DRILL 14 TAN| ZERO-P VA CAGE |