BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

    MDR report key: 3202682 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-03928
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE RETURNED SCREW IS IN FAIR CONDITION. SINCE NO ISSUES WERE FOUND DURING DIMENSIONAL ANALYSIS ON COMPLAINT RELATED FEATURES THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION WAS CONDUCTED AND IT STATES THAT NO PRODUCT FAULT COULD BE DETECTED. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: WHEN THE SURGEON FIXED ONE BURR HOLE COVER, THE HEADS OF NINE SCREWS (4MM) WERE WORN, SO HE COULD NOT FIT THE BURR HOLE COVER. THE OPERATION TIME WAS DELAYED AND THE PATIENT TOOK A FURTHER BURDEN, PROCEDURE WAS COMPLETED. THIS IS 2 OF 8 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302356 MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C JEY SYNTHES GMBH 8270906

    Patients

    Seq Age Sex Outcome Treatment
    1