CIF EI H 4MM 4DEG S
Report
- Report Number
- 3013730328-2025-00052
- Event Type
- Injury
- Date Received
- October 17, 2025
- Date of Event
- September 11, 2025
- Manufacturer
- EIT EMERGING IMPLANT TECHNOLOGIES GMBH
- Product Code
- OVD
- UDI-DI
- 04260397080016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: H3, H4, H6: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE. AS EVIDENCE OF MIGRATION WAS NOT SHARED, THE ALLEGATION WAS UNABLE TO BE CONFIRMED. A DIMENSIONAL INSPECTION WAS PERFORMED AND MET SPECIFICATIONS. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE CIF EI H 4MM 4DEG S WOULD HAVE NOT CONTRIBUTED TO THE REPORTED ADVERSE EVENT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW (DHR): PART# CEI4040S. LOT # 148117. MANUFACTURING SITE: NYPRO HEALTHCARE BAJA INC. SUPPLIER: (B)(4). QUANTITY- (B)(4). RELEASE TO WAREHOUSE DATE: 07.11.2024. EXPIRATION DATE: 31.10.2034. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. H11 ADDITIONAL NARRATIVE: ADDED: B5. CORRECTED: H5. 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. H11 ADDITIONAL NARRATIVE: ADDED: B5, E1 (INITIAL REPORTER EMAIL). CORRECTED: E1 (INITIAL REPORTER FIRST NAME, LAST NAME), H6 (HEALTH EFFECT - CLINICAL CODE). RECAPTURED CODES ON H6 (TYPE OF INVESTIGATION). 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. H11 ADDITIONAL NARRATIVE: ADDED: D6A, D6B AND D9. H3, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT #(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
ADDITIONAL INFORMATION RECEIVED: THE CURRENT NARRATIVE IS LACONIC. " THE IMPLANTED CERVICAL INTERVERTEBRAL CAGE SEEMED TO BE MIGRATED FROM THE ORIGINAL POSITION BY TAKING A POST-OPERATIVE IMAGE. REVISION SURGERY WAS NEEDED 5 DAYS LATER." WHERE THE CONCERNED IMPLANT MIGRATED TO?- IMPLANTS FOR INTERBODY FUSION SHOULD BE STAY FIRMLY WHERE THEY POSITIONED. I DON¿T KNOW ABOUT THE EXTENT OF MOVEMENT SINCE I HAVEN¿T SEEN THE IMAGE TAKEN AFTER SURGERY. WHERE IS THE CONCERNED IMPLANT? IT WAS SENT BACK TO YOU FOR INSPECTION. WHAT IS THE CURRENT CLINICAL STATUS OF THE PATIENT? I DON¿T HAVE INFORMATION. HAS THE IMPLANT BEEN EXPLANTED? YES, AS IT WAS MENTIONED IN THE ORIGINAL REPORT. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? YES.
ADDITIONAL INFORMATION RECEIVED: A. THE CURRENT NARRATIVE IS LACONIC. " THE IMPLANTED CERVICAL INTERVERTEBRAL CAGE SEEMED TO BE MIGRATED FROM THE ORIGINAL POSITION BY TAKING A POST-OPERATIVE IMAGE. REVISION SURGERY WAS NEEDED 5 DAYS LATER." THE ORIGINAL SURGERY DONE ON (B)(6) WAS A MULTI-SEGMENT ONE. THEY PUT ONE CAGE INTO THE C4-C5 INTERVERTEBRAL SPACE AND ANOTHER OF THE SAME KIND (CONDUIT CIF) INTO THE C5-C6 INTERVERTEBRAL SPACE. THEY DIDN¿T APPLY ANTERIOR CERVICAL PLATE. B. WHERE THE CONCERNED IMPLANT MIGRATED TO? POST-OP AN 50% (!) FORWARD SLIPPAGE OF THE INFERIOR CAGE WAS SEEN FROM THE DISK SPACE WHEN TOOK CONTROL IMAGING AND THE PATIENT COMPLAINING ABOUT DYSPHAGIA WHEN EATING SOLID FOOD. C. WHAT IS THE CURRENT CLINICAL STATUS OF THE PATIENT? AFTER A SUCCESSFUL REVISION SURGERY ON (B)(6) THE PATIENT IS WELL AND COMPLAINT FREE. SURGEONS REMOVED AND EXCHANGED THE SLIPPED CAGE AND EXCHANGED TO A NEW ONE. THEY DIDN¿T APPLY ANTERIOR CERVICAL PLATE THIS TIME EITHER. NEVERTHELESS, BOTH OF THE CAGES ARE FIRMLY IN THEIR PLACE.
IT WAS REPORTED THE IMPLANTED CERVICAL INTERVERTEBRAL CAGE SEEMED TO BE MIGRATED FROM THE ORIGINAL POSITION BY TAKING A POST-OPERATIVE IMAGE. REVISION SURGERY WAS NEEDED 5 DAYS LATER. PROCEDURE: ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2828383 | CIF EI H 4MM 4DEG S | INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR | OVD | EIT EMERGING IMPLANT TECHNOLOGIES GMBH | 148117 | 04260397080016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |