BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 4304810 · Received December 8, 2014

    Report

    Report Number
    2520274-2014-15195
    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

    (B)(4): THIS REPORT IS FOR AN UNKNOWN QUANTITY FOR AN POLYETHYLENE INLAY FOR PRODISC-L WITH UNKNOWN PART AND LOT NUMBERS. (B)(4): 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. (B)(4).

    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 REPLACEMET (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 2 IS A (B)(6) MALE WHO HAD A 1 LEVEL PRODISC-L TDR DUE TO A HERNIATED DISC AND RADICULOPATHY AT L4-5. HE IS REFERRED TO AS THE NON-HYBRID CASE AND HIS IMPLANT SHOWED SIGNS OF ABRASION AND IMPINGEMENT AND INFLAMMATION WAS OBSERVED IN TISSUE LESIONS WITH METAL AND POLYETHYLENE WEAR DEBRIS (AKA, PAIN, OSTEOLYTIC CYSTS, WEAR DEBRIS AND INFLAMMATION). THIS IS REPORT 6 OF 6 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PRODISC-L, POLYETHYLENE INLAY. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790587 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention