BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9542005 · Received January 2, 2020

    Report

    Report Number
    1030489-2020-00015
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Report Date
    February 6, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 75447535, 510K # K042025 AND UDI # (B)(4) 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-L5. POST-OP, THE SCREW AT L4 LOOSENED. R EPORTEDLY, SUPERIOR ADJACENT SEGMENT DISEASE WAS EXPERIENCED BY THE PATIENT DUE TO THIS EVENT. HENCE, A REVISION WAS PLANNED TO BE PERFORMED ON (B)(6) 2019 TO REPLACE THE LOOSENED SCREW. IT WAS ALSO PLANNED TO PERFORM SCREW INSERTION AT L3 AS WELL; AND TO PERFORM CONNECTION BETWEEN L3 AND L5. NO INFORMATION IS AVAILABLE IF THIS REVISION HAS BEEN PERFORMED YET.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS FOR THE INITIAL PROCEDURE: LUMBAR SPINAL CANAL STENOSIS AT FIRST, THE SALES REP HAD HEARD THAT THE SCREWS WERE LOOSE; AND IT WAS PLANNED TO PERFORM REMOVAL OF THE SCREWS DURING REVISION SURGERY. BUT ON THE REVISION SURGERY DATE, IT WAS CHECKED THAT THE SCREWS WERE NOT LOOSE; AND HENCE, REPLACEMENT WAS NOT PERFORMED. PATIENT¿S POST-OPERATIVE HEALTH CONDITION HAS BEEN REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3072 CD HORIZON SPINAL SYSTEM KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention