BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX LOCKING CAP WITHOUT SADDLE

    MDR report key: 4574442 · Received March 5, 2015

    Report

    Report Number
    2520274-2015-11473
    Event Type
    Injury
    Date Received
    March 5, 2015
    Report Date
    February 13, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    PK120838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAMES: MNH, MNI, KWO, KWP. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED A PATIENT HAD A L4-S1 FUSION PERFORMED ABOUT 1 YEAR AGO. CONSULTANT WAS NOTIFIED ON (B)(4) 2015 THAT A REVISION PROCEDURE WOULD BE SCHEDULED FOR (B)(6) 2015 DUE TO A L5-S1 NON-UNION. REVISION CONFIRMED BROKEN SCREWS AT S1 ON LEFT AND RIGHT SIDE. THE L4-L5 SCREWS WERE REMOVED, DIAMETER OF SCREWS INCREASED AND PLACED IN NEW CAVITIES. AT S1, THE BOTTOM 3RD OF THE BROKEN SCREWS ON LEFT AND RIGHT SIDE WERE LEFT IN PATIENT AND NEW SCREWS WERE IMPLANTED. SURGEON CONTINUED WITH TLIF REVISION USING A NON-SYNTHES PART, WENZEL VARIABLE LIFT GRAFT, AND IMPLANTED NEW RODS AND NEW CAPS. THIS REPORT IS 5 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153644 MATRIX LOCKING CAP WITHOUT SADDLE ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention