BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILL-SAW-ATTACHM-II CRESCENTIC TECHNIQ

    MDR report key: 3200886 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-03922
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 3, 2013
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. RETRACTING MEDWATCH: UPDATED DEVICE REPORT WAS RECEIVED: INFORMATION WAS REVIEWED AND THE EVENT IS NO LONGER REPORTABLE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE SAW ATTACHMENT FELL APART; THE GEAR IS MISSING. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303373 OSCILL-SAW-ATTACHM-II CRESCENTIC TECHNIQ HWE 1464943

    Patients

    Seq Age Sex Outcome Treatment
    1