BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/75MM

    MDR report key: 3180853 · Received June 20, 2013

    Report

    Report Number
    2520274-2013-03515
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 22, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). SCREWS WERE NOT EXPLANTED. SCREWS WERE RE-TIGHTENED DURING REVISION SURGERY. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH VA LCP DISTAL FEMUR PLATE AND LOCKING SCREWS ON (B)(6) 2013 FOR DISTAL FEMUR FRACTURE. DURING A POST-OP VISIT ON UNKNOWN DATE IT WAS DISCOVERED THAT ONE OF THE LOCKING SCREWS HAD BACKED OUT. PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2013 WHERE SURGEON RE-TIGHTENED THE VA LOCKING SCREW AND ADDED TWO (2) MORE LOCKING SCREWS. PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM, NO HARM TO PATIENT. IT IS REPORTED PATIENT IS RECOVERING WELL. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279731 5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/75MM SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention