BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2940951 · Received February 4, 2013

    Report

    Report Number
    2520274-2013-00695
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    February 1, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT SUFFERED FROM A DISTAL RADIUS FRACTURE AND WAS IMPLANTED WITH PLATE AND SCREW CONSTRUCT ON (B)(6) 2011. POST-OPERATIVELY, PATIENT SUFFERED FROM AN EXTENSOR TENDON DISRUPTION. SURGEON REPORTED THAT THIS WAS MOST LIKELY CAUSED BY A SCREW WHICH WAS POSSIBLY TOO LONG. PATIENT RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. THE FRACTURE WAS HEALED AND THE SURGEON CHOSE TO REMOVE ALL OF THE IMPLANTS. THE SURGEON DID NOT REVISE WITH ANYTHING ELSE, BECAUSE THE FRACTURE WAS HEALED. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46482 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention PLATE, SCREWS