BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI LOCKING SCREW 20MM

    MDR report key: 2103805 · Received May 18, 2011

    Report

    Report Number
    8030965-2011-00238
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 6, 2011
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    MAX
    PMA / PMN Number
    K072253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING THE INITIAL REPORT. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATES A CLINIC IN (B)(6) REPORTED: SURGEON IMPLANTED THE SYNFIX IMPLANT AND SCREWS AND DECIDED TO MOVE THE IMPLANT. HE WAS HAVING TROUBLE REMOVING ONE SCREW AND THE TIP OF THE SCREWDRIVER BROKE OFF IN THE HEAD OF THE SCREW. SURGEON DID REMOVE THE SCREW AND IMPLANT, SELECTED ANOTHER AND COMPLETED THE PROCEDURE. APPROXIMATELY 45 MINUTES WAS ADDED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM TI LOCKING SCREW 20MM 4.0MM TI LOCKING SCREW MAX SYNTHES BETTLACH NA 2669358

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention SYNFIX IMPLANT| SCREWDRIVER