BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTECEM V+ SYRINGE KIT

    MDR report key: 6269722 · Received January 23, 2017

    Report

    Report Number
    3000270450-2017-10019
    Event Type
    Injury
    Date Received
    January 23, 2017
    Report Date
    January 2, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    OAR
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. (B)(6). (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART#: 03.702.215S, LOT#: 6052681. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JUL 26, 2016, EXPIRY DATE: JUN 01, 2021. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT THE CEMENT OF A VERTECEM V+ SYRINGE KIT WAS ONLY ENOUGH FOR THREE INJECTIONS AND IT RAN OUT INTO PATIENT¿S BODY. THE DATE OF EVENT WAS NOT PROVIDED. NO INFORMATION ABOUT PATIENT OUTCOME AND SURGICAL PROLONGATION. THIS REPORT IS FOR ONE (1) VERTECEM V+ SYRINGE KIT. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53145 VERTECEM V+ SYRINGE KIT CEMENT DISPENSER OAR SYNTHES SELZACH 6052681

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention