BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCAGE-LR 45º/90º WIDE 12*28*38 PEEK

    MDR report key: 5035197 · Received August 27, 2015

    Report

    Report Number
    9612488-2015-10437
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 18, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE NOT REPORTEDLY EXPLANTED. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW ¿ MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 28. MAY 2009 EXPIRY DATE: 01. MAY 2019. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION 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 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 IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568258 SYNCAGE-LR 45º/90º WIDE 12*28*38 PEEK SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES BETTLACH 2484061

    Patients

    Seq Age Sex Outcome Treatment
    1