BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2151585 · Received June 29, 2011

    Report

    Report Number
    2520274-2011-00501
    Event Type
    Injury
    Date Received
    June 29, 2011
    Report Date
    June 3, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. MFR AND 510K CANNOT BE DETERMINED WITHOUT A PART NUMBER. DEVICE WAS NOT RETURNED AND PART/LOT NUMBERS WERE NOT PROVIDED, THE DEVICE HISTORY RECORD CANNOT BE REVIEWED. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PT EXPERIENCED A LEFT WRIST FRACTURE AND HAD A VOLAR DISTAL RADIUS PLATE AND SCREWS IMPLANTED IN (B)(6) 2008. PT REPORTS SHE BEGAN TO HAVE DIFFICULTY MOVING HER INDEX FINGER. PT WENT TO A DIFFERENT DOCTOR WHO STATED ONE SCREW WAS TOO LONG. HARDWARE WAS REMOVED IN (B)(6) 2011 AND A TENDON REPAIR WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW HWC SYNTHES (USA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS| PLATE