BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VECTRA-T-PL 4/4.5 2 SEGMENTS L55 TAN

    MDR report key: 3142560 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02594
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 9, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K051665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE IS UNKNOWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. BASED ON REVIEW OF X-RAY IMAGES IT APPEARS THAT THE PLATE IS DAMAGED AND/OR BROKEN. POSSIBLE ROOT CAUSE: INDEFINABLE WITH THE INFORMATION PRESENTED. WE CANNOT DETERMINE THE EXACT ROOT CAUSE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(4) AS FOLLOWS: THE PATIENT HAD A CERVICAL SPONDYLOTIC MYELOPATHY. THE SURGEON IMPLANTED A FIBULA INTO A SUBTOTAL REMOVAL PART (C5, 6) AND FIXED C4-7 BY VECTRA-T PLATE (SYNCAGE-C WAS USED AT C3/4) ON (B)(6) 2013. THE SURGEON REPORTED THAT THE BELOW TRANSLATION PART OF PLATE WAS SEPARATED AFTER 2 WEEKS FROM THE OPERATION. THE SURGEON DID NOT FIND ANY LOOSENESS OF SCREW. THE PLATE WAS SEPARATED UP AND DOWN AT THE SLIDING PART. IT ISN'T SEPARATED ENTIRELY AND IS ENGAGED PARTIALLY. SO THE SURGEON EXPECTS THE FIBULA WILL NOT BE DISPLACED AND DECIDED TO MONITOR THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244591 VECTRA-T-PL 4/4.5 2 SEGMENTS L55 TAN KWQ SYNTHES GMBH 2003973

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention