BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI COLLAR FOR 6MM DUAL-OPENING IMPLANTS

    MDR report key: 3881938 · Received June 18, 2014

    Report

    Report Number
    2520274-2014-11944
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    May 20, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DATE OF EVENT IS UNKNOWN. ADDITIONAL PRO CODES: MNI, MNH, KWP, KWQ. DEVICES NOT EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. 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 THAT A SURGEON PERFORMED A L4-L5 POSTERIOR LUMBAR FUSION PROCEDURE ON THE PATIENT ON (B)(6) 2013. THE SURGEON USED SYNTHES UNIVERSAL SPINE SYSTEM DUEL OPENING (USS DO) PEDICLE SCREWS AND COMPETITOR¿S TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (T-PLIF) ALLOGRAFT FOR INTERBODY FUSION. DURING AN OFFICE VISIT THE PATIENT COMPLAINED OF BACK PAIN. THE SURGEON ASSESSED THAT THE PATIENT HAD A NONUNION AT THE L4-L5 BASED ON A CT SCAN ON AN UNKNOWN DATE. ON (B)(6) 2014 SURGEON PERFORMED A L4-L5 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) TO ADDRESS THE NONUNION. THE SURGEON CLEANED OUT THE L4-L5 DISC SPACE AND REMOVED THE COMPETITOR¿S T-PLIF SPACER. THE SURGEON BURRED DOWN THE DISC SPACE TO SMOOTH OUT THE END PLATES. THE SURGEON REVISED THE PATIENT TO A COMPETITOR¿S FRA 13MM ALLOGRAFT SPACER. THERE WAS NO REVISION TO THE (USS DO) POSTERIOR HARDWARE, ALSO THERE IS NO PLANNED SURGERY TO REVISE HARDWARE AT THIS TIME. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 7 OF 14 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356971 TI COLLAR FOR 6MM DUAL-OPENING IMPLANTS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention