BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIN SCREW DIAM. 2MM LG 14MM

    MDR report key: 1930199 · Received November 18, 2010

    Report

    Report Number
    9615741-2010-00061
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 18, 2010
    Manufacturer
    NEWDEAL S.A.S.
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A SURGICAL PROCEDURE, THE TIP OF THE SCREW HEAD BROKE OFF WHEN THE DOCTOR WAS TRYING TO INSERT THE SPIN SCREW DURING SURGERY INVOLVING THE SECOND METATARSUS. IT WAS DIFFICULT FOR THE SURGEON TO REMOVE THE TIP OF THE SCREW. INTEGRA HAS REQUESTED ADD'L CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIN SCREW DIAM. 2MM LG 14MM SPIN HWC NEWDEAL S.A.S. EGKZ

    Patients

    Seq Age Sex Outcome Treatment
    1