UNK CAGE/SPACER: EIT - ALIF
Report
- Report Number
- 3013730328-2023-00078
- Event Type
- Malfunction
- Date Received
- July 27, 2023
- Date of Event
- July 10, 2023
- Manufacturer
- EIT EMERGING IMPLANT TECHNOLOGIES GMBH
- Product Code
- OVD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4 ¿ 510K: THIS REPORT IS FOR AN UNKNOWN ALIF CAGE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, 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. 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.
THE INITIAL COMPLAINT WAS REVIEWED, AND THE UNK CAGE/SPACER: EIT - ALIF WAS DETERMINED TO BE NOT REPORTABLE. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS CLARIFIED THAT THERE WAS NO ALLEGATION AGAINST THE UNK CAGE/SPACER: EIT - ALIF. THE ALLEGATION REPORTED AGAINST THE INSERTER IS CAPTURED IN MRW 3013730328-2023-00077.
THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE NOT GENERATED. PATIENT OUTCOME: A GOOD OUTCOME WAS ACHIEVED.
IT WAS REPORTED DURING A ALIF SURGERY ON (B)(6) 2023, THE IMPLANT INSERTER BECAME JAMMED. THE SURGEON HAD IMPLANTED AN ALIF CAGE. TO GET A GOOD X-RAY HE DEATTACHED THE ALIF IMPLANT INSERTER. FOLLOWING THE X-RAY HE WANTED TO USE THE INSERTER TO REPOSITION THE CAGE. HE REATTACHED THE INSERTER AND REPOSITIONED HOWEVER HE WAS THEN UNABLE TO DEATTACH THE INSERTER FROM THE IMPLANT AS THE SILVER KNOB AT THE TOP OF THE INSERTER WAS JAMMED. IN ORDER TO REMOVE THE INSERTER, HE HAD TO USE A BRISO TO BREAK THE SILVER KNOB AT THE TOP OF THE INSERTER. THIS ALLOWED HIM TO REMOVE THE OUTER SHAFT AND THEN MANUALLY REMOVE THE INNER SHAFT WITH HIS FINGERS. A REPEAT X-RAY WAS TAKEN AND THE CAGE REMAINED IN A GOOD LOCATION. THIS REPORT IS FOR ONE UNK CAGE/SPACER: EIT - ALIF FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 755499 | UNK CAGE/SPACER: EIT - ALIF | INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR | OVD | EIT EMERGING IMPLANT TECHNOLOGIES GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |