BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 13522750 · Received February 14, 2022

    Report

    Report Number
    1030489-2022-00150
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    January 25, 2022
    Report Date
    February 14, 2022
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG# 75446545, 510K# K042025, UDI # (B)(4). WAS CLEARED IN THE UNITED STATES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG# 75446545 , 510K# K042025 , UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING USE OF THE REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS MENTIONED AS L4 / 5 CAGE MOVEMENT. IT WAS REPORTED THAT, L4 / 5PLIF FUSION IN THE CASE OF RE-DECOMPRESSION WAS PERFORMED ON (B)(6) 2021. L4/L5 CAGE MOVEMENT WAS SEEN DURING FOLLOW-UP. THERE WAS LOOSENESS OF SCREW ALSO REPORTED. THE L4/L5 SCREW WAS REMOVED, AND SCREWS WERE PLACED AGAIN INTO L3/4/5/S. CAGE WAS INSERTED AGAIN DURING RE-OPERATION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 AND THE CAGES WERE RE-INSERTED. THE LOOSENESS OF SCREW WAS IDENTIFIED DURING THE REVISION SURGERY. THE CAGES WERE IMPLANTED AND REMAINS IN SERVICE AND THE SCREWS, ROD WERE EXPLANTED ¿ COMPLETE. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING USE OF THE REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS MENTIONED AS L4 / 5 CAGE MOVEMENT. IT WAS REPORTED THAT, L4 / 5PLIF FUSION IN THE CASE OF RE-DECOMPRESSION WAS PERFORMED ON (B)(6) 2021. L4/L5 CAGE MOVEMENT WAS SEEN DURING FOLLOW-UP. THERE WAS LOOSENESS OF SCREW ALSO REPORTED. THE L4/L5 SCREW WAS REMOVED, AND SCREWS WERE PLACED AGAIN INTO L3/4/5/S. CAGE WAS INSERTED AGAIN DURING RE-OPERATION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 AND THE CAGES WERE RE-INSERTED. THE LOOSENESS OF SCREW WAS IDENTIFIED DURING THE REVISION SURGERY. THE CAGES WERE IMPLANTED AND REMAINS IN SERVICE AND THE SCREWS, ROD WERE EXPLANTED ¿ COMPLETE. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90739 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG G75448545 H5617356

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male