BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 4304815 · Received December 8, 2014

    Report

    Report Number
    2520274-2014-15184
    Event Type
    Injury
    Date Received
    December 8, 2014
    Date of Event
    August 28, 2014
    Report Date
    November 10, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: VERUVA, S.Y., LANMAN, T.H., HANZLIK, J.A., KURTZ, S.M., AND STEINBECK, M.J. (2014). CASE REPORT: RARE COMPLICATIONS OF OSTEOLYSIS AND PERIPROSTHETIC TISSUE REACTIONS AFTER HYBRID AND NON-HYBRID TOTAL DISC REPLACEMENT. EUROPEAN SPINE JOURNAL, DOI 10.1007/S00586-014-3535-0. THIS WAS A RETROSPECTIVE REVIEW OF A STUDY IN WHICH THE PURPOSE WAS TO REPORT 2 OSTEOLYSIS CASES AFTER PRODISC-L LUMBAR DISC REPLACEMENT. THE STUDY POPULATION INCLUDED 2 MALE PATIENTS. THEY SUFFERED FROM LUMBAR DISC HERNIATION AND RADICULOPATHY. ONE PATIENT REQUIRED A MULTI-LEVEL TREATMENT AND CHOSE A HYBRID FIXATION WITH PRODISC-L TOTAL DISC REPLACEMENT (TDR) AND FUSION. THE OTHER PATIENT RECEIVED 1 LEVEL OF PRODISC-L TDR. BOTH PATIENTS HAD REVISION SURGERY IN WHICH THE TDRS WERE REMOVED. PERIPROSTHETIC TISSUE SPECIMENS SELECTED FROM REGIONS ADJACENT TO THE IMPLANT WERE OBTAINED. BOTH PATIENTS DEVELOPED OSTEOLYTIC LESIONS IN VERTEBRAE ADJACENT TO THE IMPLANT. PATIENT 1 IS A (B)(6) MALE WHO HAD MULTI-LEVEL TREATMENT FOR DISCOGENIC COLLAPSE WITH LOWER BACK PAIN AND RADICULOPATHY AT L5-S1. HE IS REFERRED TO AS THE HYBRID CASE AND EXPERIENCED HETEROTOPIC OSSIFICATION AND TISSUE NECROSIS DUE TO THE WEAR-INDUCED INFLAMMATION (AKA, PAIN, OSTEOLYTIC CYSTS, WEAR DEBRIS AND INFLAMMATION). THIS IS REPORT 2 OF 6 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN INFERIOR ENDPLATE PRODISC-L WITH UNKNOWN PART AND LOT NUMBERS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790782 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention