BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW

    MDR report key: 2860803 · Received December 6, 2012

    Report

    Report Number
    2520274-2012-03625
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Report Date
    September 4, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTS THAT DURING A PLANNED IMPLANT REMOVAL IT WAS NOTICED THAT 3 PROXIMAL SCREWS WERE BROKEN. ALL 3 SCREWS COULD BE REMOVED WITHOUT PROLONGATION OF THE OP. NO HARM TO THE PATIENT. THE REMOVAL WAS PERFORMED BECAUSE THE PATIENT WAS FULLY HEALED. THIS REPORT IS #3 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREWS