BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER CORTICAL SCREW SELF-TAPPING

    MDR report key: 3242925 · Received July 19, 2013

    Report

    Report Number
    1822565-2013-01129
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    April 13, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE EXACT CAUSE OF THE ALLEGED FRACTURE. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SCREW FRACTURED DURING SURGERY. THE THREADED PORTION REMAINS IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339005 ZIMMER CORTICAL SCREW SELF-TAPPING HWC ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1