BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW AXSOS 4.0MM/L70MM

    MDR report key: 2924445 · Received December 14, 2012

    Report

    Report Number
    8031020-2012-00299
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 30, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K050512
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICE: 437304 PROXIMAL LATERAL TIBIA PLATE TS AXSOS FOR LEFT TIBIA 4 HOLE/L121MM LOT# UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE SURGEON WAS USING A PROXIMAL LATERAL TIBIA PLATE (ON PT'S LEFT SIDE) AND THE LOCKING SCREW BOUND UP HALFWAY THROUGH THE PLATE AND THE PLATE AND SCREW HAD TO BE REMOVED AS A RESULT. SURGEON USED A NEW PLATE AND SCREW AND COMPLETED THE CASE WITHOUT ANY DELAY OR ADVERSE CONSEQUENCE TO PT OR USER. THE SCREW AND PLATE WILL BE RETURNED - HOSPITAL "DECON".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW AXSOS 4.0MM/L70MM IMPLANT HWC STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other