BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ CEMENT KIT

    MDR report key: 7338263 · Received March 14, 2018

    Report

    Report Number
    8030965-2018-52027
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    February 12, 2018
    Report Date
    February 14, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 510K#: K090432 PENDING APPROVAL. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR: PART NUMBER: 07.702.016S, SYNTHES LOT NUMBER: 7C53190, MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 14.JUN.2017. EXPIRY DATE: 01.MAR.2020. 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. INVESTIGATION SUMMARY: THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PRODUCT WAS NOT RETURNED, THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. 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 ON AN EVENT IN AUSTRIA AS FOLLOWS: IT WAS REPORTED, THAT VERTECEM V+ MIXING HANDLE COULD ONLY BE MOVED WITH A GREAT AMOUNT OF FORCE. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180986 VERTECEM V+ CEMENT KIT POLYMETHYLMETHACRYLATE BONE NDN OBERDORF SYNTHES PRODUKTIONS GMBH 7C53190

    Patients

    Seq Age Sex Outcome Treatment
    1