BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAX "SUSANNA"

    MDR report key: 4652169 · Received March 27, 2015

    Report

    Report Number
    MW5041780
    Event Type
    Injury
    Date Received
    March 27, 2015
    Report Date
    March 27, 2015
    Manufacturer
    ACUMED
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 SURGERY PERFORMED ON LEFT WRIST WITH ACUMED LAX "SUSANNA" (B)(4), THE SCREW (1 OF 6 PLACED) MOVED CAUSING THE TENDON TO RUPTURE TO THE LEFT THUMB WHICH WILL REQUIRE A SECOND SURGERY TO REMOVE PLATE/SCREWS TO PREVENT RECURRING DAMAGE TO REPLACEMENT TENDON OR OTHERS IN THE LEFT HAND, BELIEVE EITHER SCREW FAILED TO "LOCK" IN PLACE OR SHIFTED AFTER SURGERY. DEFECT WITH PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205510 LAX "SUSANNA" WRIST SCREWS HWC ACUMED

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other OTC MEDS: ALEVE| RX MEDS: SYNTHROID