BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACU-LOC® 2 VDR PLT, NARROW, R

    MDR report key: 8099903 · Received November 23, 2018

    Report

    Report Number
    3025141-2018-00330
    Event Type
    Injury
    Date Received
    November 23, 2018
    Report Date
    October 26, 2018
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K102998
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINED PLATE AND FOUND NOTHING TO INDICATE THAT THE PLATE WAS THE CAUSE OF SCREW BREAKAGE. EXAMINED PLATES THREADED HOLES WITH 5-44 THREAD GAGE; ALL HOLES PASSED INSPECTION. CHECKED THREAD TRAJECTORIES WITH TARGETING GUIDE 80-0696 (BATCH 243668) AND THREAD-IN BARRELS; NO ISSUE FOUND. ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: 3025141-2018-00329: SCREW.

    Description of Event or Problem · 1

    A SCREW THAT HAD BEEN PLACED IN AN ACULOC2 VDR PLATE BROKE POST OP AS SEEN ON X-RAY BEFORE ROUTINE HARDWARE REMOVAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939209 ACU-LOC® 2 VDR PLT, NARROW, R PLATE, FIXATION, BONE HRS ACUMED LLC 70-0359-S 405883

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention