BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIN SCREW DIAM. 2MM LG 14MM

    MDR report key: 4113658 · Received September 17, 2014

    Report

    Report Number
    9615741-2014-00042
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    HWC
    PMA / PMN Number
    K991477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED (DURING SURGERY) THE SCREW DID NOT BREAK AT THE CORRECT LOCATION (AT THE TOP OF THE HEAD) BUT AT THE LEVEL OF THE THREADS. THERE WAS NO ADVERSE CONSEQUENCE OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575613 SPIN SCREW DIAM. 2MM LG 14MM SPIN HWC NEWDEAL SAS EGKZ

    Patients

    Seq Age Sex Outcome Treatment
    1