BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI NUT 11MM WIDTH ACROSS FLATS

    MDR report key: 3870158 · Received June 12, 2014

    Report

    Report Number
    2530088-2014-10157
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    May 16, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWP
    PMA / PMN Number
    PK091689
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. REVIEW OF THE DHR SHOWS NO DISCREPANCIES ASSOCIATED WITH THIS COMPLAINT. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4).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 THE PATIENT UNDERWENT A T10-S1 SCOLIOSIS CORRECTION ON (B)(6) 2014. AN UNKNOWN QUANTITY OF X-RAYS TAKEN ON (B)(6) 2014 SHOWED THE ROD HAS DISPLACED ON THE LEFT SIDE AT S1. THE PATIENT WAS BROUGHT BACK TO SURGERY ON (B)(6) 2014. IT WAS ALSO DISCOVERED THAT THE SCREW, COLLAR AND NUT WERE STILL INTACT, BUT LOOSE AT THE LEFT S1. THE RIGHT S1 SCREW HAD ALSO PULLED OUT. THE CONSTRUCT WAS REVISED WITH LARGER SCREWS. PATIENT WILL BE UNDER CONTINUED MONITORING. THE SURGEON FELT THE COMPLICATION WAS DUE TO THE PATIENT¿S PHYSICAL CONDITION. THIS IS REPORT 6 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347571 TI NUT 11MM WIDTH ACROSS FLATS APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP SYNTHES BRANDYWINE 6929700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention