BEUDAMED
    FDA Adverse Event Other Summary report: N

    PCM CERVICAL DISC SYSTEM

    MDR report key: 3163076 · Received May 29, 2013

    Report

    Report Number
    2031966-2013-00019
    Event Type
    Other
    Date Received
    May 29, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 3, 2013
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MJO
    PMA / PMN Number
    P100012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SURGEON REPORTED THE PATIENT WAS VERY SLIGHT IN STATURE. THE SMALLEST SIZE PCM PRODUCT WAS IMPLANTED. THE PATIENT REPORTED PAIN SHORTLY AFTER SURGERY. SURGEON EVALUATION NOTED FACET JOINT MISALIGNMENT THAT IN REVISION SURGERY ON (B)(6) 2013; A 5 MM PROSTHESIS WAS IMPLANTED. NO RADIOGRAPHS HAVE BEEN RECEIVED CONFIRMING THE REPORTED EVENT. EXPLANTED PRODUCT IS EXPECTED TO BE RETURNED. IF ADDITIONAL RELEVANT INFORMATION IS GAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. REVIEW OF MANUFACTURING RECORDS NOTED NO NON-CONFORMANCES. NO PRIOR IMPLANT COMPLAINTS HAVE BEEN RECEIVED FOR THE ASSOCIATED LOTS. LABELING REVIEW: "CORRECT SELECTION OF THE APPROPRIATE IMPLANT SIZE AND CORRECT PLACEMENT OF THE DEVICE ARE ESSENTIAL TO ENSURE OPTIMAL PERFORMANCE AND FUNCTION OF THE DEVICE. BEFORE SELECTION OF THE IMPLANT, IT IS ALSO IMPORTANT TO NOTE: THE PRESENCE OF ANATOMICAL ABNORMALITIES AND/OR DEFORMITIES MAY REDUCE THE POSSIBILITY OF THE SURGEON TO ENSURE PROPER PLACEMENT OF THE IMPLANT." "RISKS ASSOCIATED WITH IMPLANTS IN THE SPINE, INCLUDING THE PCM CERVICAL DISC DEVICE, ARE: EARLY OR LATE LOOSENING OF THE COMPONENTS; DISASSEMBLY; BENDING OR BREAKAGE OF ANY OR ALL OF THE COMPONENTS; IMPLANT MIGRATION; MALPOSITIONING OF THE IMPLANT; LOSS OF PURCHASE; SIZING ISSUES WITH COMPONENTS."

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATING THAT FOLLOWING IMPLANTATION OF CERVICAL PROTHESES, THE PATIENT'S FACE JOINTS WERE MISALIGNED; THIS RESULTED IN SIGNIFICANT PAIN. NO PATIENT INJURY HAS OCCURRED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2013. A SMALLER PROSTHESIS WAS IMPLANTED. PATIENT IS REPORTEDLY DOING WELL FOLLOWING REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234029 PCM CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO NUVASIVE, INC. 7680265 SV8095

    Patients

    Seq Age Sex Outcome Treatment
    1