BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCM CERVICAL DISC SYSTEM

    MDR report key: 3983503 · Received June 26, 2014

    Report

    Report Number
    2031966-2014-00044
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 26, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MJO
    PMA / PMN Number
    P100012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT HAS BEEN CONFIRMED VIA RADIOGRAPH. THE INFERIOR PLATE OF THE PCM IMPLANT APPEARS TO HAVE MIGRATED OUT OF THE DISC SPACE ANTERIORLY. REVISION SURGERY WAS PERFORMED ON (B)(6) 2014; HOWEVER, THE EXPLANTED DEVICE IS STILL BEING RETAINED BY THE HOSPITAL AND HAS NOT BEEN RETURNED TO NUVASIVE FOR EVALUATION. NO ROOT CAUSE HAS BEEN IDENTIFIED. REVIEW OF THE DHR FOR LOT# SV8130 INDICATES THAT ALL SPECIFICATIONS WERE MET DURING MANUFACTURING. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE DURING EVALUATION OF THE EXPLANTED PRODUCT, A SUBSEQUENT REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PROSTHESIS WAS IMPLANTED ON (B)(6) 2014 IN THE C6-7 DISC SPACE; IN ADDITION, AN ACDF WAS PERFORMED AT THE ADJACENT INFERIOR LEVEL, C7-T1. IN A FOLLOW-UP VISIT IN (B)(6) 2014, THE INFERIOR PLATE OF THE PCM PROSTHETIC EXHIBITED ANTERIOR MIGRATION SUFFICIENT TO REQUIRE REVISION SURGERY ON (B)(6) 2014. NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373874 PCM CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO NUVASIVE, INC. 7680465 SV8130

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention