BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM

    MDR report key: 2943559 · Received February 5, 2013

    Report

    Report Number
    8030965-2013-00316
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 10, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWP
    PMA / PMN Number
    K113364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH PLATE AND SCREWS ON (B)(6) 2011. SURGERY FOR FIRST MTP FUSION TO REMOVE HARDWARE WAS PERFORMED ON (B)(6) 2013. THE PATIENT WAS COMPLAINING OF PAIN FOR THE PAST WEEK, WEEK OF (B)(6). AN X-RAY ON (B)(6) 2013 REVEALED A BROKEN PLATE. THE PLATE WAS BROKEN IN THE MIDDLE OVER THE OSTEOTOMY, ALL OTHER HARDWARE WAS FINE. IT WAS REPORTED THAT THE PLATE BROKE DUE TO A DELAYED UNION. THE SURGERY WENT WELL. THIS IS 6 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47569 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM LOCKING SCREW SLF-TPNG KWP SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention