BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - SET SCREW

    MDR report key: 2801489 · Received October 12, 2012

    Report

    Report Number
    9610622-2012-00457
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 26, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HWC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: 4060-0090S LAG SCREW, STST GAMMA3 10.5X90MM LOT NO. K631084, 4125-1180S TROCHANTERIC NAIL KIT, STST GAMMA3 11X180MM X 125, LOT NO K120201, 1796-5040S LOCKING SCREW, FULLY THREADED S2 5X40MM, LOT NO K964586.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THE FOLLOWING ON BEHALF OF THE SURGEON: "DR TREATED A PT WITH A GAMMA3 NAIL. THE SURGEON SAID THAT THIS OPERATION WENT ACCORDING TO THE PROCEDURES. AFTER TWO WEEKS THE LAG SCREW PENETRATED THE FEMORAL HEAD AND THE ACETABULUM. THE SURGEON INDICATED THAT THEY SUSPECTED THAT THE PT FELL AND THAT THIS POSSIBLY IS THE CAUSE OF THE DISPLACEMENT OF THE SCREW. HOWEVER, IN THE SURGEON'S OPINION, THE SET SCREW SHOULD HAVE PREVENT THIS FROM HAPPENING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - SET SCREW IMPLANT HWC STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R