BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9585563 · Received January 14, 2020

    Report

    Report Number
    1030489-2020-00062
    Event Type
    Injury
    Date Received
    January 14, 2020
    Report Date
    January 14, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    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

    OUTCOMES TO ADVERSE EVENT: OTHER - FRACTURE PMA/510K: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 778216555, 510K #K090390, UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: ADJACENT SEGMENT DISEASE (ASD) PROCEDURE: WITHOUT FUSION AT TH3-TH10, POSTERIOR LUMBAR FUSION (PLF) AND POSTERIOR SPINAL FUSION(PSF) AT TH10-L5, POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT L5/S WERE PERFORMED AFTER ANTERIOR FIXATION WAS PERFORMED AT L1-L4. LEVELS IMPLANTED: TH3-PELVIC IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE ONE SIDE OF THE SET SCREW WHICH WAS ON THE OPEN SIDE OF THE CONNECTOR PLACED AT LEVEL TH-11 WAS BACKED OUT. PATIENT DID NOT ACHIEVE SOLID FUSION AS BONE FRACTURE ONSET AT T11. THE PATIENT WAS HOSPITALIZED AGAIN FOR THE RE-OPERATION AS A RESULT OF THIS EVENT AND UNDERWENT REVISION SURGERY ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48500 CD HORIZON SPINAL SYSTEM KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R