BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 11743632 · Received April 29, 2021

    Report

    Report Number
    1030489-2021-00541
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 29, 2021
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: DEVICE IS NOT MARKETED IN US. A SIMILAR DEVICE IS MARKETED IN US WITH 510K NO. K121680 WITH PRODUCT ID AS 1475006500. 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 HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF LUMBAR NONUNION DUE TO IMPLANT DAMAGE, UNDERGOING A REVISION SURGERY. IT WAS REPORTED THAT, ADOPTED V4 ON (B)(6) 2020 (BKP AT L1 AND FIXATION AT 2ABOVE-2BELOW). WHEN THE PATIENT BENT HIS HIPS AND TRIED TO LIFT A HEAVY LOAD, THE RODS BROKE AND RE-OPERATION WAS REQUIRED. THE RODS WERE BROKEN BETWEEN TH11 / L2, AND BOTH SIDES WERE BROKEN. ROD REPLACEMENT WAS PERFORMED IN THIS OPERATION. THERE WERE NO ADDITIONAL PATIENT SYMPTOMS/COMPLICATIONS. INITIAL REPORTER INFORMATION AND PATIENT INFORMATION CANNOT BE PROVIDED DUE TO THE RESTRICTION BY THE PRIVACY REGULATION. THE PRODUCT WAS DISCARDED AND REPLACED. DATE OF INITIAL SURGERY: (B)(6) 2020. TYPE AND LEVEL OF INITIAL SURGERY: FOR L1 LUMBAR COMPRESSION FRACTURE, BKP WAS PERFORMED AT L1 AND FIXATION WITH SCREW VOYAGER4.75 WAS PERFORMED AT TH11-L3. DEVICE STATUS REASON : EXPLANTED-COMPLETE THE RE-OPERATION WAS COMPLETED SUCCESSFULLY. THE PATIENT ISSUE WAS RESOLVED BY REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645742 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS 1476106130 0665689W

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention