BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10647247 · Received October 8, 2020

    Report

    Report Number
    1030489-2020-01395
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Report Date
    October 8, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8699070, UDI# (B)(4), 510K #K981676 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

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH AN INDICATION OF LOWER LIMBS SYMPTOMS ON L5-S1 WITHOUT KNOWING THE CAUSE. IT WAS REPORTED THAT PLIF WAS PERFORMED ON L4-5 BEFORE (B)(6) 2019. IMPLANT ON L4-5 WAS REMOVED AND PLIF WAS PERFORMED ON L5-S1 WITH ISBS (INTRA SACRAL BUTTRESS SCREW) ON (B)(6) 2019. FUSION WAS EXTENDED TO L2-3-4 ON (B)(6) 2019. FUSION WAS EXTENDED TO THORACIC SPINE IN 2020. THIS TIME, ROD BREAKAGE WAS NOTED ON THE CAUDAL SIDE OF MRC OF THE RIGHT ROD ON L5-S1 WHERE HAD BEEN PERFORMED FUSION FOR EXTENDING. THE LOOSESCREW WAS REPLACED, AND FUSION WAS PERFORMED AGAIN. AS A RESULT, THE ONSET OF LEG PAIN DUE TO ROD BREAKAGE WAS HEAVY AND LOWER LIMBS SYMPTOMS OF L5-S1. NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THERE WAS PROLONGATION OF EXISTING OR IN-HOUSE HOSPITALIZATION FOR DECOMPRESSION AND FUSION. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. PRODUCT USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112987 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS G8699070 0674279W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention