BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 5899578 · Received August 24, 2016

    Report

    Report Number
    1030489-2016-02410
    Event Type
    Injury
    Date Received
    August 24, 2016
    Date of Event
    July 22, 2016
    Report Date
    July 26, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 83565509, 510K #K090740 WAS CLEARED IN THE UNITED STATES. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION (PLF) SURGERY AT L5-S1 LEVEL, FOR THE TREATMENT OF SPONDYLOLISTHESIS. DURING SURGERY, A PEDICLE SCREW DEVIATED FROM L5. REPORTEDLY, THERE WAS A DELAY OF MORE THAN 60 MIN AS A RESULT OF THIS EVENT. POST-OP, PATIENT REPORTED NUMBNESS IN LOWER LIMBS. REVISION SURGERY HAD TO BE PERFORMED ON AN UNKNOWN DATE TO REINSERT THE DEVIATED PEDICLE SCREW. REPORTEDLY, AFTER RE-INSERTION OF THE PEDICLE SCREW, IT IS EXPECTED THAT PATIENT'S PAIN WILL DISAPPEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552317 TSRH SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R