BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 4771757 · Received May 14, 2015

    Report

    Report Number
    2530088-2015-10234
    Event Type
    Injury
    Date Received
    May 14, 2015
    Report Date
    April 28, 2015
    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. THIS REPORT IS FOR AN UNKNOWN PRODISC-L POLYETHYLENE INLAY / UNKNOWN QUANTITY/UNKNOWN LOT. REPORTER PHONE NUMBER: (B)(6). (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

    LITERATURE ARTICLE RECEIVED: ¿THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: REFERENCE: LEBEL, D. (2012). IN VIVO FUNCTIONAL PERFORMANCE OF FAILED PRODISC-L DEVICES. SPINE. VOLUME 37, PP E1209-E1217. USA¿ THIS ARTICLE DISCUSSES A RETRIEVAL ANALYSIS OF WEAR MODES AND FIXATION OF LUMBAR TOTAL DISC REPLACEMENTS (TDRS). EXPLANTED PRODISC-L TDRS WERE PROSPECTIVELY COLLECTED DURING A 7-YEAR PERIOD BETWEEN 2005 AND 2011 AND ANALYZED. THE PURPOSE OF THE STUDY WAS TO ASSESS THE IN VIVO MODES OF WEAR AND FIXATION OF LUMBAR TDR WITH THE PRODISC-L DEVICE. NINETEEN PRODISC-L DEVICES FROM 18 PATIENTS WERE EXPLANTED FOR PAIN, PROTHESIS SUBLUXATION/MIGRATION, END PLATE COLLAPSE/SUBSIDENCE, POLYETHYLENE DISLODGEMENT, AND UNKNOWN CAUSES. THIS REPORT IS FOR DEVICES 11 AND 12. DEVICES 11 AND 12 WERE EXPLANTED FROM A (B)(6) FEMALE PATIENT. DEVICE 11 WAS IMPLANTED AT LEVEL L4-L5, THE IMPLANT SIZE WAS MEDIUM, AND THE POLYETHYLENE SIZE WAS 10MM. THE DEVICE WAS EXPLANTED DUE TO LOWER BACK PAIN (LBP). THE SURGEON-REPORTED PRESENTATION WAS LBP. ANALYSIS OF THE EXPLANTED DEVICE SHOWED POSTERIOR BURNISHING ON THE SUPERIOR COMPONENT, RIGHT BURNISHING ON THE INFERIOR COMPONENT, POSTERIOR POLYETHYLENE DETERIORATION, BACKSIDE WEAR, THIRD BODY WEAR, 30% SUPERIOR COMPONENT ONGROWTH, AND 10% INFERIOR COMPONENT ONGROWTH. DEVICE 12 WAS IMPLANTED AT LEVEL L5-S1, THE IMPLANT SIZE WAS MEDIUM, AND THE POLYETHYLENE SIZE WAS 10MM. THE DEVICE WAS EXPLANTED DUE TO LOWER BACK PAIN (LBP). THE SURGEON-REPORTED PRESENTATION WAS LBP. ANALYSIS OF THE EXPLANTED DEVICE SHOWED POSTERIOR BURNISHING ON BOTH COMPONENTS, BACKSIDE WEAR, THIRD BODY WEAR, 10% SUPERIOR COMPONENT ONGROWTH, AND 2% INFERIOR COMPONENT ONGROWTH. THIS REPORT IS 32 OF 48 FOR (B)(6). THIS REPORT IS FOR AN UNKNOWN PRODISC-L DEVICE, UNKNOWN PART#/LOT#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316943 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention