BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNEX SPREADER F/MIS

    MDR report key: 3132191 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02444
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION HAS SHOWN THAT THE THREADED ROD M10 IS BROKEN AND THE CONNECTING BOLT IS BENT. IT IS OBVIOUS THAT THE BREAKAGE AND DAMAGE OCCURRED DURING THE ASSEMBLY OF THE SYNEX SPREADER. TOO MUCH APPLIED MECHANICAL FORCE CAUSED THE BENDING OF THE CONNECTING BOLT. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING THE OPERATION, WHEN THE DOCTOR WAS SPREADING THE INPLANT USING THE SYNEX SPREADER , A BLACK METALLIC PART WAS BROKEN DUE TO THE OVERLOAD OF THE SYNEX SPREADER. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237100 SYNEX SPREADER F/MIS HTD SYNTHES GMBH 3273475

    Patients

    Seq Age Sex Outcome Treatment
    1