BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ SYRINGE KIT

    MDR report key: 3241457 · Received July 22, 2013

    Report

    Report Number
    8030965-2013-04390
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 28, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OAR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    AN ANALYSIS WAS CONDUCTED AND IT STATES THAT THE RETURNED PRODUCTS MATCH ACCORDING TO OUR SPECIFICATIONS AND NO DAMAGES ARE FOUND. THE MANUFACTURING DOCUMENTS OF THIS LOT HAVE BEEN CHECKED AND NO DEVIATION WAS FOUND. NO PRODUCT FAULT WAS FOUND.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, IT WAS NOT POSSIBLE TO FILL THE SYRINGES. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340760 VERTECEM V+ SYRINGE KIT OAR SYNTHES GMBH 2091447

    Patients

    Seq Age Sex Outcome Treatment
    1