BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE, SURGICAL, INSTRUMENT

    MDR report key: 5035195 · Received August 27, 2015

    Report

    Report Number
    2520274-2015-15532
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 18, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT IS FOR ONE (1) UNKNOWN INSERTION HOLDER. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. (B)(6). 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. 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 EU REPORTS AN EVENT IN (B)(6) AS FOLLOWS: AFTER THE IMPLANTATION OF A PEEK CAGE IN LWK 4/5, THERE WAS NO TANTUM MARKER IN THE AP AND LATERAL X-RAY, SO NEITHER DEVICE COULD BE IDENTIFIED. THE IMPLANT INSERTION HOLDER WOULD NOT HOLD DURING IMPLANTATION, THUS THE PEEK CAGE HAD TO BE INSERTED FREE-HAND USING THE CAGE POSITIONING AID. THE EXACT LOCATION OF THE IMPLANTS COULD NOT BE CONFIRMED. THERE WAS REPORTEDLY 20 MINUTES SURGICAL DELAY. THIS COMPLAINT IS FOR ONE (1) UNKNOWN INSERTION HOLDER. THIS IS REPORT 2 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568356 GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1