BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10827237 · Received November 12, 2020

    Report

    Report Number
    1030489-2020-01631
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    August 3, 2020
    Report Date
    November 12, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS:PART # 5430230, LOT # H5508146 VISUAL AND OPTICAL INSPECTION REVEALED THE TIP OF THE DRIVER HAS BROKEN OFF AND STUCK IN THE HEAD OF THE SET SCREW. THE THREADS HAVE BEEN DAMAGED FROM THE REMOVAL PROCESS. THE SET SCREW CAN NO LONGER BE USED DUE TO THE THREAD DAMAGE AND THE JAMMED BROKEN INSERTER TIP. PMA/510K: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5440230, 510K #K112473 , UPN# (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 · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF(TRANSFORAMINAL LUMBAR INTERBODY FUSION) ON L4/5 AND PLIF(POSTERIOR LUMBAR INTERBODY FUSION) ON L5/S1 DUE TO L4 SPONDYLOLISTHESIS, L5 ISTHMIC SPONDYLOLISTHESIS, LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT REDUCTION SET SCREW WAS INSERTED, ROD WAS PLACED, REDUCTION OPERATION WAS PERFORMED WITH DRIVER, WHEN THE FINAL TIGHTENING WAS PERFORMED, FORCE WAS APPLIED AS IT WAS AND THE TIP OF THE DRIVER BROKE. THE BROKEN TIP REMAINED ON SET SCREW BEFORE PERFORMING THE BREAK-OFF FOR SET SCREW, SO THE SET SCREW WAS REMOVED BY THE PLIERS OF HOSPITAL, AND IT WAS REPLACED WITH A NEW SET SCREW, THE FINAL TIGHTENING WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT SYMPTOMS/COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE WAS AN OVERALL PROCEDURE DELAY OF LESS THAN 60 MINS. THE PRODUCT WAS REPLACED. THERE WAS NO FRAGMENT REMAINED IN THE PATIENT¿S BODY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295024 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG 5430230 H5508146

    Patients

    Seq Age Sex Outcome Treatment
    1