BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNAP-OFF SCREW 2.7MM LENGTH 12MM

    MDR report key: 2593055 · Received May 24, 2012

    Report

    Report Number
    9615741-2012-00033
    Event Type
    Injury
    Date Received
    May 24, 2012
    Date of Event
    May 18, 2012
    Report Date
    May 24, 2012
    Manufacturer
    NEWDEAL SAS
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    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 SNAP OFF SCREW WOULD NOT SNAP, CAUSING DAMAGE TO THE BONE. THIS LED TO THE SURGEON HAVING TO REPEAT THE OSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SNAP-OFF SCREW 2.7MM LENGTH 12MM NA HWC NEWDEAL SAS E7PE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other