BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREW, STST 10.5X95MM

    MDR report key: 1981645 · Received January 12, 2011

    Report

    Report Number
    9610622-2011-00003
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 15, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN AT THIS TIME IF THE DEVICES WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. ADDITIONAL LOT K297368.

    Description of Event or Problem · 1

    RISK MANAGER FROM THE HOSPITAL, REPORTED THE ALLEGED EVENT : DURING A SURGERY, THE CERVICAL SCREW WAS IMPOSSIBLE TO BE INSERTED INTO THE NAIL. THE RISK MANAGER FROM THE HOSPITAL. THERE WAS NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREW, STST 10.5X95MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K128738/K29604

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other