BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 40MM

    MDR report key: 2871711 · Received December 13, 2012

    Report

    Report Number
    1719045-2012-01352
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER A MANUFACTURING RECORD REVIEW CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    PATIENT WITH LEFT SHOULDER IMPLANT OF 3.5MM LCP PROXIMAL HUMERAL PLATE AND EIGHT SCREWS ON (B)(6) 2012 PRESENTED WITH SLIGHT COLLAPSE OF THE HUMERAL HEAD FOLLOWING A FALL ON HER LEFT SHOULDER. PATIENT RETURNED TO OR FOLLOWING THE FALL ON HER LEFT SHOULDER. SURGEON REMOVED 6 INTACT SCREWS AND REPLACED WITH SHORTER SYNTHES SCREWS. REMOVED SCREWS WERE DISCARDED. THIS IS THE 4TH OF 7 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 40MM 3.5MM LOCKING SCREW KTT SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention PLATE, SCREWS