BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI USS LOW PROFILE FRACTURE CLAMP

    MDR report key: 3914885 · Received July 4, 2014

    Report

    Report Number
    2520274-2014-12392
    Event Type
    Malfunction
    Date Received
    July 4, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE BROKEN DURING INSERTION; DEVICE WAS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE OPERATION, AT THE FINAL TIGHTENING PROCESS, WHEN THE SURGEON WAS TIGHTENING THE GOLDEN SCREW WITH A SCREW DRIVER, THE SCREW THREAD BROKE, AND THE SCREW DRIVER RAN IDLE. DUE TO THIS INCIDENT, THE SURGEON WAS NOT ABLE TO FIX THE SCREW AND REPLACED IT WITH A NEW ONE. THERE WAS A TWENTY MINUTE DELAY IN THE PROCEDURE. NO PIECE OF THE SCREW WAS LEFT IN THE PATIENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392804 TI USS LOW PROFILE FRACTURE CLAMP ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1