BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT LARGE 5MM-STERILE

    MDR report key: 2903461 · Received January 9, 2013

    Report

    Report Number
    2520274-2013-00184
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PRODUCT DEVELOPMENT REVIEWED THE HSS REPORT RECEIVED: THERE IS NO NEW EVIDENCE OF DEVICE FAILURE OR MAL-FUNCTION THAT WARRANTS FURTHER ACTIONS AND NO NEW RISKS CAN BE IDENTIFIED. THE FINDINGS OF THE REPORT REGARDING THE CONDITION OF THE IMPLANT ARE CONSISTENT WITH THE PRODUCT DEVELOPMENT EVALUATION FOUND IN THIS COMPLAINT. NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. REMOVING THE DISEASED DISC IS SUPPOSED TO REMOVE THE SOURCE OF THE PATIENTS PAIN. SINCE THE PATIENT MAY HAVE CONTINUED TO EXPERIENCE PAIN OR STARTED TO HAVE PAIN AGAIN 9 MONTHS POST OPERATIVELY AFTER THE ORIGINAL PRODISC-C IMPLANTATION, THE SURGEON MAY HAVE FAILED TO REMOVE ONE OR MORE OF THESE PAIN GENERATORS. THE PRODISC-C TECHNIQUE GUIDE SPECIFICALLY STATES: PERFORMING A COMPLETE AND METICULOUS DISCECTOMY, DECOMPRESSION, AND REMOBILIZATION OF THE DISC SPACE IS CRITICAL TO THE SUCCESS OF THE SURGERY. PATIENT SELECTION COULD ALSO HAVE PLAYED A ROLE. IF THE SOURCE OF THE PAIN WAS UNKNOWN AT THE TIME OF SURGERY, THEN THE PRODISC-C IMPLANT MAY NOT HAVE TREATED THE SOURCE OF THE PROBLEM AT THE TIME OF IMPLANTATION. UNDER THE PRECAUTIONS SECTION IN THE TECHNIQUE GUIDE, IT CAUTIONS THAT THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH NECK OR ARM PAIN OF UNKNOWN ETIOLOGY. MYELOPATHY OR PAIN IS ALSO LISTED ON THE PRODISC-C PACKAGE INSERT AS ONE OF THE SEVERAL POTENTIAL RISKS ASSOCIATED WITH THIS DEVICE AND IN GENERAL WITH THE IMPLANTATION OF SPINAL IMPLANTS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INFORMATION RECEIVED INDICATES REMOVAL. LOT #: LOT NUMBER WAS PROVIDED. DEVICE WAS REMOVED ON AN UNKNOWN DATE. REVIEW OF MANUFACTURING RECORDS FOUND ALL PARTS WERE MANUFACTURED TO SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED ON (B)(6) 2012 THAT A PATIENT WAS EXPERIENCING NECK PAIN, NINE MONTHS FROM THE IMPLANT ON (B)(6) 2012. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IMPLANT WAS REMOVED ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11251 PRODISC-C IMPLANT LARGE 5MM-STERILE PRODISC-C IMPLANT LARGE 5MM-STERILE MJO 6422458

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention