BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACDF STAND ALONE CERVICAL

    MDR report key: 21907807 · Received April 25, 2025

    Report

    Report Number
    3005180920-2025-00345
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    March 26, 2025
    Report Date
    May 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVE
    UDI-DI
    07630040725644
    PMA / PMN Number
    K192906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28-03-2025: LOT 2462307: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-10-2024. EXPIRATION DATE: 2029-10-06. 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 IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 28-03-2025: ACDF 03.18.206 MECTA-C SA LOCK PLATE - FLUSH H6 (K192906) LOT 2462309: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-12-2024. EXPIRATION DATE: 2029-11-21. 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. ACDF 03.18.206 MECTA-C SA - PLATE FLUSH LOCK H6 (K192906) LOT 2462427: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-12-2024. EXPIRATION DATE: 2029-11-18. 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. ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7° (K192906) LOT 2459750: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-07-2024. EXPIRATION DATE: 2029-06-30. 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. INVESTIGATION PERFORMED BY R&D PROJECT MANAGER. THE MECTA-C SA LOCK PLATE (REF 03.18.206, LOT NO. 2462309) DETACHED IN SITU FROM THE MECTA-C SA CAGE (REF 03.18.110, LOT NO. 2462307) DURING SCREW INSERTION. FROM THE INTRAOPERATIVE X-RAY, IT CAN BE OBSERVED THAT THE SCREW IS FULLY SEATED IN THE PLATE, BUT THE PLATE IS DETACHED FROM THE CAGE. BASED ON THE PICTURES RECEIVED, IT IS APPARENT THAT THE CAGE IS BROKEN: A FRACTURE STARTS FROM THE CENTRAL HOLE AND EXTENDS TOWARDS THE SCREW GROOVES. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE OF THE COMPLAINT COULD BE THAT DURING SCREW INSERTION, SINCE THE TRAJECTORY OF THE SCREW WAS NOT CORRECT, THE PLATE WAS FORCED TILL DETACHMENT.

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT: DURING AN ACDF SURGERY, THE MECTA-C SA LOCK PLATE BECAME DETACHED FROM THE MECTA-C SA CAGE DURING SCREW INSERTION. THE AVAILABLE X-RAY IMAGES SHOW THE CRANIAL SCREW FULLY SEATED, WHILE THE PLATE APPEARS DETACHED FROM THE CAGE. THE AVAILABLE PICTURES OF THE CAGE INDICATE THAT IT IS BROKEN. ALTHOUGH WE DO NOT YET HAVE DEFINITIVE EVIDENCE, ONE POSSIBLE FAILURE MECHANISM COULD BE A MISALIGNMENT BETWEEN THE SCREW AND THE CAGE'S SCREW HOLE. THIS MISALIGNMENT MAY HAVE GENERATED ABNORMAL FORCES, POTENTIALLY LEADING TO CAGE FRACTURE AND PLATE DETACHMENT. IT HAS BEEN REPORTED THAT THIS TYPE OF ISSUE OCCURRED WITH TWO CAGES; HOWEVER, THE AVAILABLE X-RAY IMAGE AND PICTURES REFER TO ONLY ONE OF THEM. VISUAL INVESTIGATION PERFORMED DY R&D DEPARTMENT THE MECTA-C SA LOCK PLATE (REF. 03.18.206, LOT NO. 2462309) DETACHED IN SITU FROM THE MECTA-C SA CAGE (REF. 03.18.110, LOT NO. 2462307) DURING SCREW INSERTION. FROM THE INTRAOPERATIVE X-RAY, IT CAN BE OBSERVED THAT THE SCREW IS FULLY SEATED IN THE PLATE, BUT THE PLATE IS DETACHED FROM THE CAGE. BASED ON THE PICTURES AND THE DEVICES RECEIVED, IT IS APPARENT THAT THE CAGE IS BROKEN: A FRACTURE STARTS FROM THE CENTRAL HOLE AND EXTENDS TOWARDS THE SCREW GROOVES. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE OF THE COMPLAINT COULD BE THAT DURING SCREW INSERTION, SINCE THE TRAJECTORY OF THE SCREW WAS NOT CORRECT, THE PLATE WAS FORCED TILL DETACHMENT. REGARDING THE FIRST, NOT IMPLANTED, CAGE AND PLATE FAILURE OF ASSEMBLING, ALTHOUGH THE SPECIFIC CIRCUMSTANCES CANNOT BE CONFIRMED, THE ROOT CAUSE OF THE ISSUE IS LIKELY RELATED TO THE MISALIGNMENT OF THE SCREW TRAJECTORY AND THE CAGE'S SCREW HOLE. THIS MISALIGNMENT MAY HAVE LED TO UNEXPECTED FORCES ON THE CAGE AND PLATE RESULTING IN PLATE DETACHMENT. REGARDING THE SECOND, IMPLANTED, IT IS NOT POSSIBLE TO ESTABLISH A DEFINITIVE ROOT CAUSE, WHILE THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE. CORRECTION: B2. DEVICE EVALUATION: D9. H3.

    Description of Event or Problem · 0

    DURING INSERTION OF THE LOCKING SCREW THE FLUSH LOCK PLATE CAME LOOSE FROM THE CAGE. THE SURGEON RECOUPLED THE PLATE AND THE CAGE AND TRIED AGAIN TO INSERT THE SCREW BUT THE PLATE CAME LOOSE AGAIN. NEW CAGE AND PLATE WERE USED TO COMPLETE THE SURGERY. THE SAME ISSUE OCCURRED AGAIN WITH A SECOND CAGE ON A DIFFERENT LEVEL: THE PLATE CAME LOOSE, THE SURGEON RECOUPLED IT TO THE CAGE AND IN THIS CASE WAS ABLE TO COMPLETE SCREW INSERION WITHOUT ISSUES. PATIENT WAS YOUNG WITH GOOD BONE QUALITY, DISTRACTION WAS PERFORMED WITH CASPAR DISTRACTOR. IT WAS REPORTED THAT THE SURGEON DID NOT TRY TO REPOSITION THE CAGES ONCE IN SITU AND BEFORE SCREWING. 20 TO 30 MINUTES OF DELAY REPORTED, TOTAL SURGERY TIME AROUND 2H.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289921 ACDF STAND ALONE CERVICAL MECTA-C SA TIPEEK CAGE 16X14X6X7° OVE MEDACTA INTERNATIONAL SA 03.18.110 2462307 07630040725644

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O