BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2840068 · Received October 17, 2012

    Report

    Report Number
    2520274-2012-02330
    Event Type
    Injury
    Date Received
    October 17, 2012
    Report Date
    September 19, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT. THE SCREW IS DESIGNED FOR THE TEMPORARY FIXATION OF BONE FRAGMENTS; EITHER WITH THE ASSISTANCE OF A PLATE OR STAND ALONE. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE COMPLAINT EVENT. THE SCREWS RETURNED DID NOT FAIL MECHANICALLY. UPON REMOVAL OF THE HARDWARE, DUE TO PATIENT DISCOMFORT, THE SURGEON REPORTED THAT THE FRACTURE APPEARED TO HAVE HEALED AND DID NOT REAPPLY NEW HARDWARE. THE COMPLAINT IS NOT HARDWARE RELATED. THE EXACT CIRCUMSTANCES THAT LED TO THE PATIENTS DISCOMFORT OR THE MANNER IN WHICH THE SCREWS WERE ACTUALLY IMPLANTED IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    MEDWATCH UF# 340010-2012-67 WAS RECEIVED, A COPY WILL BE INCLUDED WITH THE REPORT. THIS IS 8 OF 14 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREWS| PLATE