BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI NUT 11MM WIDTH ACROSS FLATS

    MDR report key: 5141199 · Received October 9, 2015

    Report

    Report Number
    2520274-2015-16557
    Event Type
    Injury
    Date Received
    October 9, 2015
    Report Date
    September 29, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    KWP
    PMA / PMN Number
    PK141897
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF POSTOPERATIVE EVENT IS UNKNOWN. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE: MNI AND MNI. THE ORIGINAL IMPLANT PROCEDURE TOOK PLACE ON AN UNKNOWN DATE IN (B)(6) 2013. IT IS UNCLEAR IF THE COMPLAINANT PART WAS REMOVED DURING THE REVISION PROCEDURE ON (B)(6), 2015. HOWEVER, IT WILL NOT BE AVAILABLE FOR RETURN FOR MANUFACTURER EVALUATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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 UNDERWENT AN L5-L1 SPINAL FUSION PROCEDURE USING A SYNTHES UNIVERSAL SPINE SYSTEM IN (B)(6) 2013. ON AN UNKNOWN DATE, SOMETIME FOLLOWING THE ORIGINAL PROCEDURE, THE PATIENT WAS HIT BY A CAR WHILE RIDING A BIKE. THEREAFTER, THE PATIENT DEVELOPED A NONUNION AND THE RIGHT S1 SCREW WAS DISCOVERED TO BE BROKEN. ON (B)(6) 2015, THE PATIENT UNDERWENT A REVISION SURGERY DURING WHICH THE DISTAL TIP OF THE RIGHT S1 SCREW WAS LEFT IN THE PATIENT. THE SURGEON DECIDED THAT IT COULD CAUSE MORE OF A PROBLEM IF AN ATTEMPT TO REMOVE THE BROKEN TIP WAS MADE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF A SURGICAL DELAY. THIS REPORT IS 8 OF 14 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671172 TI NUT 11MM WIDTH ACROSS FLATS APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention