BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6953990 · Received October 17, 2017

    Report

    Report Number
    1030489-2017-02214
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Report Date
    November 17, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 6430530, 510K# K143375 AND (B)(4) IS APPROVED FOR SALE IN US. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    X-RAY REVIEW: POST OP X-RAYS FROM INSTRUMENTATION OF CONGENITAL LUMBAR CAVITY AT L4 TO "L6" SHOW BACKOUT OF ONE OF THE L4 SET SCREWS. THERE IS A LARGE BONY PSEUDOARTHROSIS ANTERIORLY AND THE NAMED L5 LEVEL APPEARED TO HAVE BEEN SKIPPED. THE HARDWARE ALSO APPEARED UNDERSIZED. THESE FACTORS CONTRIBUTE TO FAILURE OF THE CONSTRUCT. ROOT CAUSE IS SURGICAL TECHNIQUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE SET SCREW ON THE RIGHT SIDE OF L4 BACKED OUT IN THE PATIENT WHO HAD SURGERY APPROXIMATELY ONE YEAR AGO. THE PATIENT DID NOT NOTICE ANY CHANGES IN HIS BODY BECAUSE HE HAS CONGENITAL INSENSITIVITY TO PAIN WITH ANHIDROSIS. NO PATIENT COMPLICATIONS WERE REPORTED. CLEAR ZONE WAS CONFIRMED AROUND RIGHT L6 SCREW. IT WAS UNKNOWN WHETHER BONY UNION WAS ACHIEVED OR NOT. RE-OPERATION WAS NOT PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734869 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1