BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, T7, 2.7X18MM

    MDR report key: 2002563 · Received January 28, 2011

    Report

    Report Number
    8010177-2011-00024
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED OBSERVATION COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE RISK ASSESSMENT RELATED TO THE FAILURE MODE AS REPORTED, REVEALED THAT THE ACTUAL OCCURRENCE LEVEL IS WITHIN THE EXPECTED AND ACCEPTED RATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD OF THE SCREW WAS BROKEN DURING TIGHTENING. THE SURGEON DID NOT USE STRONG FORCE. THE SHAFT OF THE SCREW REMAINED IN THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, T7, 2.7X18MM IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA LAC01FA651

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK