BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACDF STAND ALONE CERVICAL

    MDR report key: 21966279 · Received May 6, 2025

    Report

    Report Number
    3005180920-2025-00358
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    April 4, 2025
    Report Date
    July 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVE
    UDI-DI
    07630040726603
    PMA / PMN Number
    K192906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 APRIL 2025. LOT 2465088: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2025. EXPIRATION DATE: 2029-12-04. TO DATE, 5 ITEMS HAVE BEEN IMPLANTED. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 09 APRIL 2025: ACDF 03.18.632 MECTA-C SA DRILL SCREW LAG Ø3.8X14 (2X) LOT 2465090: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2025. EXPIRATION DATE: 2029-12-04. TO DATE, 7 ITEMS HAVE BEEN IMPLANTED. INVESTIGATION PERFORMED BY WASHING AND PACKAGING MANAGER: THE TWO LOTS INVOLVED WERE WASHED IN THE BIOWASH ON THE SAME DAY BY ONE OPERATOR. ONCE THE WASHING WAS COMPLETED, THEY WERE UNLOADED INTO ANOTHER ROOM BY A DIFFERENT OPERATOR. IT IS ASSUMED THAT THE MIX-UP OCCURRED AT THIS STAGE, DURING UNLOADING, WHEN THE TRAY WAS MISTAKENLY ASSOCIATED WITH THE WRONG ROUTE CARD. DURING PACKAGING IN THE CLEANROOM, THE OPERATOR PERFORMED THE CHECKS REQUIRED BY IL 07.17, WHICH WERE SUCCESSFULLY COMPLETED. HOWEVER, SINCE THESE ITEMS ARE NOT LOT-MARKED, THE OPERATOR DID NOT FOLLOW IL 07.35-R REV.8, WHICH SPECIFIES THAT FOR UNMARKED PRODUCTS, AT LEAST ONE ITEM PER LOT MUST BE CHECKED ACCORDING TO FINAL CONTROL INSTRUCTION 08.10.022-R REV.0. THE ACTIONS ALREADY IMPLEMENTED TO MITIGATE THE RISK OF MIX-UPS FOLLOWING THIS EVENT INCLUDE THE INTRODUCTION OF TAGS TO SECURE THE ASSOCIATION BETWEEN PARTS AND ROUTE CARDS, THE INTRODUCTION OF DEDICATED CARTS FOR THE BIOWASH AREA TO MINIMIZE THE MOVEMENT OF RACKS, AND THE REVISION OF THE FLOW MANAGEMENT INSTRUCTION IL 07.35-R AND THE BIOLOGICAL WASHING INSTRUCTION IL 07.03. WE WILL ALSO PROCEED WITH REVISING THE CONTROL INSTRUCTIONS, WITH A FOCUS ON UNMARKED PRODUCTS, MAKING THEM EVEN SIMPLER AND MORE STRAIGHTFORWARD TO APPLY. CAPA FILE HAS BEEN OPEN TO PREVENT A REOCCURRENCE OF THE EVENT. RECALL HAS BEEN INITIATED TO REMOVE THE ITEMS FROM THE MARKET. US WAS NOT INVOLVED.

    Additional Manufacturer Narrative · 0

    ALL THE PIECES OF THE TWO LOTS HAVE BEEN RETRIEVED FROM THE MARKET AND WERE RECEIVED AT M.INT WAREHOUSE. THERE WA NO PIECES IN US. THE ROOT CAUSE OF THE MIX UP IS RELATES TO A LACK OF EFFECTIVE COMPONENT VERIFICATION DURING PRODUCTION OF THE TWO LOT NUMBERS INVOLVED.

    Description of Event or Problem · 0

    DURING SURGERY, INSIDE THE PACKAGING OF MECTA-C SA DRILL SCREWS LOCK Ø3.8X14 (X2) (REF 03.18.622 LOT 2465088), MECTA-C SA DRILL SCREWS LAG Ø3.8X14 (X2) (REF 03.18.632) WERE FOUND INSTEAD. NEW SCREWS LOCK OF DIFFERENT REF WERE USED TO COMPLETE SUCCESSFULLY THE SURGERY. SINCE THE SCREWS ARE NOT LOT-MARKED, IT WAS NOT POSSIBLE TO IDENTIFY THE LOT OF THE ITEMS FOUND INSIDE THE PACKAGING. BY REVIEWING THE PRODUCTION DATA SHIFT, IT WAS FOUND OUT THAT ON THE SAME DAY (06 DEC 2024), ONLY ONE SIMILAR PRODUCT (REF 03.18.632 LOT 2465090) HAS BEEN PACKAGED. THIS MATCHES THE PRODUCT THAT WAS FOUND UPON OPENING THE PACKAGING (REF 03.18.632) ALLOWING TO CONCLUDE THAT A FULL SWAP OF SUBCOMPONENTS OCCURRED BETWEEN THE TWO LOTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1885433 ACDF STAND ALONE CERVICAL SPINE ACDF MECTA-C SA DRILL SCREW LOCK Ø3.8X14 (2X) OVE MEDACTA INTERNATIONAL SA 03.18.622 2465088 07630040726603

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other