BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCM CERVICAL DISC SYSTEM

    MDR report key: 4063101 · Received July 7, 2014

    Report

    Report Number
    2031966-2014-00046
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 1, 2014
    Report Date
    July 7, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MJO
    PMA / PMN Number
    P100012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT HAS BEEN CONFIRMED VIA RADIOGRAPH. TWO PROSTHESES WERE IMPLANTED AT THE C5-C6 AND C6-C7 SPINE LEVELS. THE INFERIOR END-PLATE OF THE C5-C6 PROSTHESIS APPEARS TO HAVE MIGRATED. THE EXPLANTED DEVICE HAS BEEN RETURNED; EVALUATION IS ONGOING AT THIS TIME. NO ROOT CAUSE HAS BEEN IDENTIFIED. THE PCM PROSTHETIC DEVICE HAS BEEN EVALUATED FOR, AND IS APPROVED FOR SINGLE-LEVEL SPINAL CORRECTION. THE FACT THAT TWO PCM DEVICES WERE IMPLANTED AT ADJACENT LEVELS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: "THE PCM CERVICAL DISC IS INDICATED FOR USE IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF A DEGENERATED CERVICAL DISC AT ONE LEVEL FROM C3-C4 TO C6-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY". "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; ANATOMICAL OR TECHNICAL DIFFICULTIES".

    Description of Event or Problem · 1

    TWO PROSTHESES WERE IMPLANTED ON (B)(6) 2014 AT THE C5-C6 AND C6-C7 DISC SPACES. IN (B)(6) 2014, (3 MONTHS POST-OP), RADIOGRAPHS INDICATED THAT THE INFERIOR PLATE OF THE MORE CRANIAL PROSTHESIS IN C5-C6 HAD MIGRATED ANTERIORLY. REVISION SURGERY OCCURRED ON (B)(6) 2014 TO REMOVE THE DEVICE FROM C5-C6 AND PERFORM A PLATED ANTERIOR FUSION AT THAT SPINAL LEVEL INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395053 PCM CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO NUVASIVE, INC. 7680372 SV8073

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention