BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN SPINAL SYSTEM

    MDR report key: 7449445 · Received April 21, 2018

    Report

    Report Number
    1030489-2018-00580
    Event Type
    Malfunction
    Date Received
    April 21, 2018
    Date of Event
    March 22, 2018
    Report Date
    April 21, 2018
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    OVD
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7969214, 510K #K091813 AND UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT 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

    PRE-OPERATIVE DIAGNOSIS: SPONDYLODESE L5-S1. TYPE OF PROCEDURE: DECOMPRESSION L5-S1 <(>&<)> VENTRALE SPONDYLODESE L5-S1 WITH ANTERIOR LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT DURING SURGERY, THE SPACER CRACKED AT THE UPPER SIDE OF THE SCREW HOLE AT 180 DEGREES. THE CAGE REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292226 SOVEREIGN SPINAL SYSTEM OVD MSD DEGGENDORF MFG NA 46EY

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR