BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTER, WIRE

    MDR report key: 10343573 · Received July 30, 2020

    Report

    Report Number
    10343573
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    August 12, 2019
    Report Date
    July 24, 2020
    Manufacturer
    BOSS INSTRUMENTS LTD
    Product Code
    HXZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE CUTTING THE EXCESS ROD, THE TIP OF THE ROD CUTTER SPINE BROKE OFF AND TORE THE DURA. THE DURAL TEAR WAS THEN ASSESSED, REPAIRED WITH SUTURE AND DURAL SEALANT WAS APPLIED BY THE ATTENDING SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810099 CUTTER, WIRE HXZ BOSS INSTRUMENTS LTD 22" PIN CUTTER - SIDE CUT X-LARGE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other