BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREW LOCKING

    MDR report key: 2921382 · Received January 17, 2013

    Report

    Report Number
    2520274-2013-00451
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 20, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. DATE OF IMPLANT UNKNOWN NO PART NUMBER REPORTED, HENCE NO 510K NUMBER CAN BE PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2012, IT WAS REPORTED THAT ON AN UNKNOWN DATE A PATIENT WAS INVOLVED IN A MVA AND WAS IMPLANTED WITH A SIX-HOLE SYMPHYSEAL LOCKING PLATE WITH FOUR LOCKING SCREWS. THE PATIENT RETURNED FOR A FOLLOW UP VISIT THREE WEEKS POST IMPLANTATION. AN X-RAY TAKEN ON AN UNKNOWN DATE REVEALED UNSCREWING OF LOCKED SCREWS FROM THE PLATE, AND SCREW WAS PULLING OUT FROM BONE RESULTING FROM COMPLETE LOSS OF REDUCTION. RETROSPECTIVE ANALYSIS REVEALED THAT THE LOCKING SCREWS THAT HAD UNSCREWED AND PULLED OUT IN THE SIX-HOLE PLATE, WERE MISALIGNED WITH THE THREADS OF THE PLATE DURING THEIR SURGICAL INSERTION THIS IS 23 OF 24 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27048 UNK - SCREW LOCKING SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention PLATES, SCREWS