BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI NUT 11MM WIDTH ACROSS FLATS

    MDR report key: 3875029 · Received June 16, 2014

    Report

    Report Number
    2520274-2014-11906
    Event Type
    Injury
    Date Received
    June 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KWP
    PMA / PMN Number
    PK091689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: MNI, MNH, KWP, KWQ. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 PATIENT HAD A L4-S1 POSTERIOR LUMBAR FUSION IN (B)(6) 2011, EXACT DATE UNKNOWN. THE SURGEON USED SYNTHES UNIVERSIAL SPINE SYSTEM (USS) AND AN UNKNOWN PEEK INTERBODY CAGE (MAY BE SYNTHES, BUT THERE ARE NO RECORDS TO CONFIRM) FOR ORIGINAL SURGERY. A SECOND SURGEON SAW THE PATIENT IN (B)(6) 2013. THE PATIENT COMPLAINED OF BACK PAIN AND RIGHT L5 RADICULAR SYMPTOMS. SURGEON ASSESSED THE PATIENT HAD A NONUNION AND REQUIRED FURTHER DECOMPRESSION. SURGEON PERFORMED THE REVISION ON (B)(6) 2014. INTRAOPERATIVELY HE FOUND A NONUNION AT THE L4-L5 AND L5-S1 LEVELS. HE REMOVED ALL OF THE USS HARDWARE AND REPLACED IT WITH LARGER DIAMETER USS SCREWS. IT WAS OBSERVED DURING THE REVISION SURGERY THAT ALL SCREWS THAT WERE REMOVED WERE SLIGHTLY LOOSE IN THE BONE. HE LEFT THE INTERBODY PEEK CAGE ALONE. THE SURGEON THEN PLACED USS ILLIAC SCREWS ALONGSIDE THE ROD AND CONNECTED THEM. HE SUCCESSFULLY COMPLETED THE PROCEDURE. THIS IS REPORT 18 OF 21 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353207 TI NUT 11MM WIDTH ACROSS FLATS APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention