BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATNEU SCR Ø1.5 SELF-DRILL L5 TAN 1U I/C

    MDR report key: 3230965 · Received July 17, 2013

    Report

    Report Number
    1719045-2013-01813
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO COMPLAINT RELATED ANOMALIES. DEVICE WAS RECALLED OUTSIDE UNITED STATES.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AS THE HOSPITAL WAS PLACING THE SCREWS INTO THE SCREW RACK, THEY NOTED THAT THE NUMBER PRINTED ON THE PLASTIC SCREW HOLDER WAS 4, WHEREAS THE SCREW LENGTH WAS 5MM. THE LENGTH OF THE SCREW AS PER THE LENGTH PRINTED ON THE STICKER WAS CORRECT. THIS IS 17 OF 30 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330836 MATNEU SCR Ø1.5 SELF-DRILL L5 TAN 1U I/C JEY SYNTHES MONUMENT 7044544

    Patients

    Seq Age Sex Outcome Treatment
    1