BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UCSS

    MDR report key: 5403448 · Received February 2, 2016

    Report

    Report Number
    1030489-2016-00367
    Event Type
    Injury
    Date Received
    February 2, 2016
    Date of Event
    January 8, 2016
    Report Date
    January 8, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE NUMBER 873-036 WITH 510K NUMBER K003928 IS APPROVED FOR SALE IN THE US. NEITHER PRODUCT NOR APPLICABLE IMAGING STUDIES AVAILABLE. HENCE, IT IS DIFFICULT OT COME TO ANY CONCLUSION AS OF NOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT CERVICAL POSTERIOR FUSION FOR FRACTURE-DISLOCATIONS AT C1-C2. DURING SURGERY, THE SURGEON REPLACED A SCREW BECAUSE THE INSERTION DIRECTION TO THE LEFT OF THE SCREW WAS A LITTLE TOWARDS THE OUTSIDE THAN THE PLACE WHERE THE GUIDE WIRE WAS PASSING THROUGH. THAT TIME, THERE WAS MASSIVE BLEEDING (TOTAL 1800CC) SO THE SURGEON TRIED TO PERFORM ASTRICTION AND REPLACED SCREW AGAIN. MEANWHILE, THE SURGERY WAS STOPPED. THE SURGEON DECIDED NOT TO INSERT SCREW AT RIGHT SIDE BECAUSE THE RISK WAS HIGH AND TWO NESPLON WERE USED AT RIGHT SIDE SO IT WAS ENOUGH FOR FUSION. THE GUIDE WIRE CAME OUT SO IT WAS INSERTED AGAIN DURING DRILLING THE LEFT SIDE. INSERTED SCREW WAS SLIGHTLY ANGLED OUTWARD SO IT WAS REPLACED WITH A NEW ONE AND RE-INSERTED FROM A DIFFERENT ANGLE. BLEEDING WAS CONFIRMED DURING SCREW REMOVAL. BECAUSE OF BLEEDING, RIGHT SCREW WAS NOT INSERTED BY DOCTOR'S DECISION. PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62596 UCSS APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other