BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 125

    MDR report key: 11855540 · Received May 20, 2021

    Report

    Report Number
    3013461531-2021-00020
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    April 25, 2021
    Report Date
    May 20, 2021
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    PMA / PMN Number
    H170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIRST INVESTIGATION: THE X-RAY DEMONSTRATES THAT THE RATCHET MECHANISM HAS SHORTENED. THIS PATIENT WAS OUT OF INDICATIONS WITH LATERAL BENDING ABOVE 30 DEGREES. AS EXPECTED IN SUCH CASES THE CORRECTION WAS SUB-OPTIMAL. IN SUCH POOR CORRECTION, THE PROBABILITY OR A RATCHET PROBLEM IS HIGHER. THE BEST ASSUMPTION IN SIMILAR PAST CASES WAS THAT TISSUE GROWTH INTO THE RATCHET MECHANISM AND CAUSE THE PROBLEM. THE POOR CORRECTION TO ABOVE 40 DEGREES ENABLES EASY ROD DISTRACTION THAT MOVES THE LOCKING TOOTH. IN THE CASE OF A TISSUE INSIDE THE MECHANISM, THE LOCKING TOOTH MAY HAVE A "SLOW RETURN" TO ITS POSITION, RESULTING RATCHET BACKUP. RISK ASSESSMENT AND CORRECTIVE ACTION: THE RISK OF THE RATCHET MALFUNCTION HAS BEEN ASSESSED AND FOUND TO BE ACCEPTABLE (DMS# (B)(4)). THIS EVENT DOES NOT INCREASE THE PROBABILITY RATING. THE COMPANY HAS IMPLEMENTED CORRECTIVE ACTION RESULTING IN AN UPDATED DESIGN OF THE MID-C 125 TO INCREASE THE STRENGTH OF THE RATCHET SPRING ((B)(4)) THE INCIDENT RATE OF RATCHET MALFUNCTION BEFORE THIS MITIGATION IS (B)(4) AND FOLLOWING THIS MITIGATION STANDS AT (B)(4). THE COMPANY IMPLEMENTED AN ADDITIONAL DESIGN CHANGE OF THE STOPPER PIN ((B)(4)). THE PRESENT CASE IS THE FIRST REPORT OF RATCHET MALFUNCTION FOLLOWING THE ECO-59 MITIGATION ((B)(4)), THE COMPANY CONTINUES TO MONITOR THE EFFECTIVENESS OF THIS MITIGATION. THE TOTAL RATE OF RATCHET MALFUNCTION FOR ANY REASON IS (B)(4) AND POST-ECO- 59 , (B)(4). THE CURRENT INCIDENT RATE OF DEVICE-RELATED ADVERSE EVENTS IS WELL WITHIN THE RATE REPORTED IN THE LITERATURE. SEE CER DMS 727 REV T.

    Description of Event or Problem · 1

    THE X-RAY INDICATES RATCHET MALFUNCTION AS THE ROD IS NOW SHORTER COMPARED TO THE X-RAY TAKEN 4 MONTHS BEFORE. IN ADDITION THE PATIENT HEARS NOISE FROM THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753015 MID-C 125 POSTERIOR RATCHETING ROD SYSTEM, QGP APIFIX LTD MID-C 125 AF 10-01-19

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention