BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ CEMENT KIT

    MDR report key: 5896909 · Received August 23, 2016

    Report

    Report Number
    2520274-2016-14329
    Event Type
    Malfunction
    Date Received
    August 23, 2016
    Date of Event
    August 9, 2016
    Report Date
    August 9, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER IS UNKNOWN. THE PATIENT¿S YEAR OF BIRTH WAS REPORTED AS 1945. THE COMPLAINANT PART WAS PRODUCED PRIOR TO THE DATE IMPLEMENTED BY THE FDA REQUIRING UNIQUE DEVICE IDENTIFICATION. UDI IS NOT AVAILABLE. IMPLANT AND EXPLANT DATES: DUE TO THE INTRA-OPERATIVE ISSUES REPORTED, THE COMPLAINANT CEMENT WAS NOT FULLY IMPLANTED. THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER HOSPITAL CONTACT NUMBER: (B)(6). PMA 510(K): AT THIS TIME, THE COMPLAINANT PART IS AVAILABLE FOR EU DISTRIBUTION ONLY. A 510K NUMBER HAS YET TO BE ASSIGNED. 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 (B)(4) 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: AND VERTEBRAL BODY STENT INFLATION SYSTEM (PART: 03.804.413S / LOT: UNKNOWN / QUANTITY: 2). THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547274 VERTECEM V+ CEMENT KIT POLYMETHYLMETHACRYLATE BONE CEMENT NDN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1