BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 4340695 · Received December 18, 2014

    Report

    Report Number
    1030489-2014-04778
    Event Type
    Injury
    Date Received
    December 18, 2014
    Report Date
    November 26, 2014
    Manufacturer
    WARSAW ORTHOPEDIC, INC
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART # 808-088, # 89104EH, # 96176H, # 96101H, # 96101H, # 96133H, # 96176EH, # 810-402, # 810-403 AND # 810-404. (B)(4): PART # 808-088, 510K K932029; PART # 89104EH, 510K K943827; PART # 96176H, 510K K981676; PART # 96101H, 510K K943827; PART # 96190H, 510K K943827; PART # 96133H, 510K K943827; PART # 96176EH, 510K K943827; PART # 810-402, 510K K870830; PART # 810-403, 510K K870830; PART # 810-404, 510K K870830. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT MAY HAVE ALLERGY TO THE HARDWARE. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830603 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other RODS, SCREWS, HOOKS, CROSSLINK