BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN SPINAL SYSTEM

    MDR report key: 7062542 · Received November 28, 2017

    Report

    Report Number
    1030489-2017-02396
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    November 1, 2017
    Report Date
    March 1, 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

    PRODUCT ANALYSIS: THE SOVEREIGN SPACER WAS RETURNED WITH A CRACK RUNNING FROM THE UPPER SIDE OF THE SCREW HOLE 180 DEGREES. THERE WERE WITNESS MARKS LOCATED UNDER THE SHELF OF THE SCREW HOLE. THIS INDICATES THAT THE SCREW WAS PLACED TOO DEEP EITHER FROM FORCE OR MISALIGNMENT. ONCE THE SCREW GETS UNDER THE SHELF IT WILL START TO PLACE PRESSURE OUTWARDLY ON THE IMPLANT LEADING TO THE IMPLANT CRACKING TO RELIEVE THE STRESS. PRODUCT IMAGE REVIEW: SUBMITTED IMAGES APPEAR TO DISPLAY CRACKED INTERBODY SPACER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: OVD - INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7968212, 510K #K091813 AND UPN (B)(4) WAS APPROVED FOR SALE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SURGERY AT L5-S1 DUE TO SPONDYLOLISTHESIS. INTRA-OPERATIVELY, THE CAGE CRACKED DURING FINAL TIGHTENING. THE CAGE WAS THEN REMOVED AND REPLACED WITH ANOTHER ONE OF THE SAME DIMENSION WITHOUT ANY PROBLEM. THERE WAS NO FRAGMENT OF THE DEVICE REMAINING INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843861 SOVEREIGN SPINAL SYSTEM OVD MSD DEGGENDORF MFG NA 204755275

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR