BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ SYRINGE KIT

    MDR report key: 6595414 · Received May 26, 2017

    Report

    Report Number
    3000270450-2017-10183
    Event Type
    Malfunction
    Date Received
    May 26, 2017
    Date of Event
    May 6, 2017
    Report Date
    May 6, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    OAR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. OTHER UDI: (B)(4). IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTERS PHONE NUMBER: (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: 03.702.215S / 6072679 MANUFACTURING LOCATION: (B)(4). SUPPLIER: SYMATESE DEVICE MANUFACTURING DATE: 28 OCT 2016, EXPIRY DATE: 01 OCT 2021. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    REMOVE EVENT DATE, DATE OF THE EVENT IS UNKNOWN. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY WHILE FILLING THE CEMENT INTO THE WHITE 2CC SYRINGES, THE STAMPS OF THE SYRINGES BACKED OUT OF THE OUTER TUBE, THE STOP WAS NOT WORKING. ALL SYRINGES HAD THE SAME PROBLEM. THERE WAS NO PATIENT HARM AND THE OUTCOME WAS FINE. THE SURGERY WAS NOT PROLONGED AND WAS SUCCESSFULLY COMPLETED. 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
    374409 VERTECEM V+ SYRINGE KIT CEMENT DISPENSER OAR SYNTHES SELZACH 6072679

    Patients

    Seq Age Sex Outcome Treatment
    1