BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10902073 · Received November 25, 2020

    Report

    Report Number
    1030489-2020-01686
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Report Date
    November 25, 2020
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT MARKETED IN U.S. 510K NO. FOR SIMILAR PRODUCT MARKETED IN U.S. WITH CATALOGUE#: 9690025 IS K043488. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH IMPLANT PRODUCT PROTRUDED TO THE DORSAL SIDE WHICH CAUSED PAIN SUGGESTED FOR SPINAL THERAPY. DATE OF INITIAL SURGERY WAS ON (B)(6) 2016. HOSPITALIZATION AND OPERATION TO PERFORM RE-OPERATION BECAUSE THE IMPLANT PRODUCT HIT AND THERE WAS A PAIN . EVENT OCCURRED DURING USE OF THE IMPLANT. INITIAL SURGERY LEVELS IMPLANTED WAS T10-SAI. IT WAS REPORTED THAT THE ROD WAS BROKEN, BUT THAT PART WAS LEFT AS IT WAS TO OBSERVE FURTHER SITUATION, THIS TIME THE HOOK ON THE FRONT MOST SIDE WAS PROTRUDING TO THE DORSAL SIDE AND IT WAS PAINFUL, SO THE ROD WAS INTENTIONALLY CUT AND THE HOOK WAS REMOVED TOGETHER. THERE WAS ROD BREAKAGE, BROKEN ROD FRAGMENT OF IMPLANT WAS IN PATIENT NOT REMOVED. REMAINING PART WAS DISCARDED BY CUSTOMER. IMPLANT WAS PARTIALLY EXPLANTED. PATIENT SYMPTOM WAS PAIN. HEALTH DAMAGE WAS REPORTED IN PATIENT. BONE FUSION WAS NOT ACHIEVED DUE TO ROD BREAKAGE. NO FURTHER COMPLICATIONS REPORTED. UPDATE ;THE HOOK AND A PART OF THE ROD WAS EXPLANTED, AND THE REMAINING ROD REMAINED IN THE PATIENT. THE EXPLANTED PART HAD BEEN DISCARDED BY THE CUSTOMER. UPDATE 2020-NOV-05 E2(REP); HOOK WAS REMOVED BECAUSE IT CAUSED PATIENT PAIN. NO PART/LOT INFORMATION IS AVAILABLE. UPDATE ; EXPLANT DATE IS THE SAME AS PLI10 (PARTIALLY) (B)(6) 2020. EVENT DATE IS UNKNOWN. PLI30, AND 40 HAVE BEEN ADDED SINCE TOTAL OF 2 RODS, AND 2 HOOKS WERE REPORTED FOR THE SAME COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367551 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS 1606300500 0347465W

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention