BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTRA-T-PL 4/4.5 4 SEGMENTS L81 TAN

    MDR report key: 3042712 · Received April 9, 2013

    Report

    Report Number
    8030965-2013-01498
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    February 6, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K051665
    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 INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THAT ON (B)(6) 2013, SURGEON FORGOT TO REMOVE A VECTRA T SPACER. HE WAS ABLE TO CONFIRM THIS AFTER TAKING POST-OPERATIVE X-RAYS. SURGEON CHOSE TO LEAVE THE SPACER IMPLANTED BECAUSE HE BELIEVED IT WAS NOT A RISK FOR THAT PATIENT. THIS IS 1 OF 1 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145525 VECTRA-T-PL 4/4.5 4 SEGMENTS L81 TAN KWQ SYNTHES GMBH 1836038

    Patients

    Seq Age Sex Outcome Treatment
    1