ACDF STAND ALONE CERVICAL
Report
- Report Number
- 3005180920-2025-00550
- Event Type
- Malfunction
- Date Received
- June 13, 2025
- Date of Event
- May 21, 2025
- Report Date
- June 13, 2025
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- OVE
- UDI-DI
- 07630040725934
- PMA / PMN Number
- K192906
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- 003
Narratives
BATCH REVIEW PERFORMED ON 27 MAY 2025: LOT 2326808: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2023. EXPIRATION DATE: 2028-11-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 27 MAY 2025: ACDF 03.18.602 MECTA-C SA DRILL SCREW LOCK Ø3.8X14 (1X) (K192906) LOT 2226827: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2023. EXPIRATION DATE: 2028-03-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: A MECTA-C SA IMPLANT (CAGE REF. 03.18.101, LOT NO. 2326796; PLATE REF. (B)(4) LOT NO. 2326808) WAS REMOVED FROM THE PATIENT AFTER A METAL BURR WAS OBSERVED PROTRUDING FROM ONE OF THE THREADED HOLES DURING SCREW INSERTION (REF. (B)(4), LOT NO. 2226827). ACCORDING TO THE EVENT DESCRIPTION, THE AWLING AND TAPPING STEPS WERE PERFORMED PRIOR TO SCREW INSERTION. UPON RECEIPT, THE COMPONENTS WERE ANALYZED: THE SCREW EXHIBITED NO DAMAGE, AND ITS OUTER DIAMETER WAS FOUND TO BE WITHIN SPECIFICATIONS. IT IS THEREFORE CONSIDERED LIKELY THAT THE METAL BURR DID NOT ORIGINATE FROM THE SCREW, BUT FROM THE PLATE, WHICH MAY HAVE BEEN DAMAGED DURING THE TAPPING PROCESS. THE POTENTIAL ROOT CAUSE OF THE COMPLAINT MAY BE CROSS-THREADING BETWEEN THE TAP AND THE PLATE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR A MECTA-C SA IMPLANT WAS EXPLANTED INTRA-OPERATIVELY AFTER A METAL BURR WAS OBSERVED PROTRUDING FROM ONE OF THE THREADED HOLES OF THE PLATE DURING SCREW INSERTION. ACCORDING TO THE EVENT REPORT, THE AWLING AND TAPPING STEPS WERE PERFORMED PRIOR TO SCREW PLACEMENT. THE ANALYSIS CONDUCTED BY THE R&D DEPARTMENT ON THE RETRIEVED IMPLANT INDICATED MOST LIKELY THAT THE METAL BURR ORIGINATED FROM THE PLATE ITSELF. THE AVAILABLE X-RAY IMAGE WAS TAKEN POSTOPERATIVELY, THEREFORE IT DOES NOT PROVIDE INSIGHT INTO THE INTRAOPERATIVE PHASE (E.G., THE INITIAL POSITION OF THE CONSTRUCT, THE DIRECTION OF TAPPING OR SCREW INSERTION). HOWEVER, THE IMAGE DOES NOT SHOW ANY EVIDENCE OF RESIDUAL METAL FRAGMENTS LEFT IN THE PATIENT, THEREFORE NO SECONDARY ISSUES FOR THE PATIENT ARE EXPECTED AS A RESULT OF THIS EVENT. NO PATIENT HARM WAS REPORTED, WITH THE ONLY NOTED IMPACT BEING A SURGICAL DELAY OF APPROXIMATELY 30 MINUTES. ALTHOUGH THE SPECIFIC CIRCUMSTANCES CANNOT BE CONFIRMED, THE POTENTIAL ROOT CAUSE OF THE EVENT IS CROSS-THREADING BETWEEN THE TAP AND THE PLATE DURING THE TAPPING PHASE. NO SYSTEMIC DEFICIENCY CAN BE IDENTIFIED AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.
AFTER PLACEMENT OF THE CAGE, THE SURGEON PREPARED THE SCREW HOLES USING AWL AND TAP. DURING SCREW INSERTION, PART OF THE THREAD (BURRS) WAS SEEN COMING OUT OF THE PLATE. THE SURGEON DECIDED TO REMOVE THE IMPLANT AND REPLACE IT WITH CAGE MECTA-C. OPERATING LEVEL C4-C6, NO ANATOMICAL ABNORMALITIES NOTED. APPROXIMATELY 30 MINUTES DELAY DURING A TOTAL SURGERY TIME OF A COUPLE OF HOURS IN ORDER TO REMOVE THE IMPLANT AND RETRIEVE THE OTHER CAGE WITH ITS DEDICATED INSTRUMENTATION. SURGERY COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 636510 | ACDF STAND ALONE CERVICAL | ACDF MECTA-C SA - PLATE TRIO LOCK H5 | OVE | MEDACTA INTERNATIONAL SA | 03.18.305 | 2326808 | 07630040725934 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |