BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST360 SET SCREW, FLAT, 1/4-28, PACKAGED

    MDR report key: 2823810 · Received October 29, 2012

    Report

    Report Number
    2184052-2012-00027
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS EXPECTED TO BE RETURNED BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OPERATIVELY, THE SET SCREW CAME LOOSE AND A SCREW WAS FOUND TO BE LOOSE AS WELL. APPROXIMATELY EIGHT MONTHS POST-OPERATIVELY, THE PATIENT PRESENTED WITH A STRONG PAIN AT THE RIGHT S1. AN MRI SHOWED THE SET SCREW HAD BACKED OUT AND THE SCREW WAS ALSO LOOSE IN THE BONE. DURING REVISION, THE SET SCREW WAS REPLACED. THE SCREW, HOWEVER, WAS NOT REMOVED DUE TO THE PATIENT'S AGE. THE SCREW WAS RE-SECURED WITH CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST360 SET SCREW, FLAT, 1/4-28, PACKAGED ST360 SET SCREW, FLAT, 1/4-28, PACKAGED KWQ ZIMMER SPINE 7055-0001-00 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention