BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 1971815 · Received January 27, 2011

    Report

    Report Number
    1030489-2011-00076
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MJO
    PMA / PMN Number
    P060018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    FUNCTIONAL EVALUATION REPLICATED CUSTOMER CONCERN REGARDING ASSEMBLY OF LOCKSCREW INTO SUPERIOR PORTION OF IMPLANT. DIMENSIONAL EVALUATION OF BOTH UPPER AND LOWER WITH GO/NO-GO THREAD GAGE REVEALS GO THREAD GAGE FAILURE IN THE SUPERIOR LOCK SCREW HOLE. DIMENSIONAL AND FUNCTIONAL EVALUATION OF BOTH LOCK SCREW THREADS WITH GO/NO-GO THREAD GAGE AND SAMPLE IMPLANT DID NOT IDENTIFY ANY DIMENSIONAL OR FUNCTIONAL ISSUE OF LOCK SCREWS. NO MATERIAL DAMAGE NOTED ON LOCK SCREWS, AND BOTH IMPLANT AND LOCK SCREWS ARE MADE OF THE SAME MATERIAL, 316 SS. ADDITIONALLY, THE IMPLANT INSERTER DOES NOT ENGAGE THE THREADS; IF THE LOCK SCREWS WERE MISALIGNED DURING INTRAOPERATIVE ASSEMBLY, THE LOCK SCREW WOULD BE ANTICIPATED TO HAVE SIMILAR DAMAGE TO THE IMPLANT DAMAGED THREADS. ). IT IS NOTED THAT ONE OF THE ORIGINAL LOCK SCREWS IS MISSING AND NOT RETURNED FOR ANALYSIS. TWO LOCK SCREWS COME PACKAGED WITH THE PRESTIGE ASSEMBLY, WITH THE SAME LOT# AS THE OTHER IMPLANTS. ONE OF THE (B)(4) LOCK SCREWS WAS NOT RETURNED. THE OTHER LOCK SCREW WITH THE SEPARATE LOT# MAY HAVE BEEN THE REPLACEMENT AVAILABLE FROM THE PRESTIGE INSTRUMENT LOANER KIT, THUS ALLOWING FOR POSSIBLE INTRAOPERATIVE MISALIGNMENT OF THE SUPERIOR PORTION OF THE DISC. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CERVICAL DISC REPLACEMENT PROCEDURE AT C5-C6, THE FINAL LOCKING SCREW WOULD NOT ENGAGE TO PLATE. SINCE THE SCREWS COULD NOT BE LOCKED DOWN ON THE SUPERIOR ASPECT OF DISC, THE ENTIRE DISC HAD TO BE REMOVED. THE SURGERY WAS CONVERTED TO AN ACDF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO MEDTRONIC SOFAMOR DANEK W08D0508

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention