BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ SYRINGE KIT

    MDR report key: 5896921 · Received August 23, 2016

    Report

    Report Number
    2520274-2016-14327
    Event Type
    Malfunction
    Date Received
    August 23, 2016
    Date of Event
    August 9, 2016
    Report Date
    August 9, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    OAR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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 CEMENT SPILLED INTO THE SPINAL CANAL OF A PATIENT DURING A VERTEBRAL BODY STENTING (VBS) AND INSTRUMENTATION PROCEDURE OF AN LWK-1 FRACTURE ON (B)(6) 2016. DUE TO THE INTRA-OPERATIVE ISSUE, THE PROCEDURE WAS PROLONGED BY APPROXIMATELY TEN (10) MINUTES, BUT WAS ULTIMATELY COMPLETED SUCCESSFULLY. IT WAS FURTHER NOTED THAT A REVISION PROCEDURE WILL NOT BE REQUIRED FOR THIS PATIENT. CONCOMITANT DEVICE(S) REPORTED: VERTEBRAL BODY STENT, SMALL (PART: 09.804.600S / LOT: UNKNOWN / QUANTITY: 2) AND VERTEBRAL BODY STENT INFLATION SYSTEM (PART: 03.804.413S / LOT: UNKNOWN / QUANTITY: 2). THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548256 VERTECEM V+ SYRINGE KIT CEMENT DISPENSER OAR SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1