BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFERIOR END PLATE MEDIUM-STERILE

    MDR report key: 3023743 · Received March 27, 2013

    Report

    Report Number
    2530088-2013-00418
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. INVESTIGATION IS STILL ON-GOING. REVIEW OF THE DHR'S AND THE RAW MATERIAL INDICATE THERE WERE NO MANUFACTURING DISCREPANCIES RELEVANT TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE POST-OP PAIN AND MIGRATION CAUSED BY THE ANTERIOR MALPOSITIONING IN THE REPORT WAS OBSERVED WITHIN 3 WEEKS POST-OP. IN THIS COMPLAINT, THE PATIENT DID NOT PRESENT WITH PAIN OR WAS NOTED TO HAVE DEVICE MIGRATION UNTIL SEVERAL YEARS AFTER SURGERY APPROXIMATELY 4YRS 8MO BETWEEN IMPLANT AND EXPLANT DATES. THIS SIGNIFICANT TIME FRAME SHOULD HAVE ALLOWED FOR POTENTIAL BONE REMODELING AROUND OR TO THE KEELS AND TITANIUM SPRAYED COATING OF THE DEVICE. SECOND, FROM A REVIEW OF THE IMAGES PRESENTED IN THE ARTICLE, THE MIGRATION INVOLVED THE ENTIRE DEVICE, BOTH THE SUPERIOR AND INFERIOR ENDPLATES. ONLY THE SUPERIOR ENDPLATE WAS NOTED TO HAVE MIGRATED IN THIS CASE. NOT ENOUGH INFORMATION HAS BEEN PROVIDED TO THEORIZE WHY THE SUPERIOR ENDPLATE WOULD MOVE ALONE IN THIS CASE WITHOUT SIGNIFICANT TRAUMA TO SEPARATE THE BALL-AND-SOCKET JOINT FORMED WITH THE POLYETHYLENE INLAY. NO X-RAYS WERE PROVIDED AT THE TIME OF THIS REVIEW TO PROVIDE CLARITY TO THE COMPLAINT DESCRIPTION. THERE IS NOT ENOUGH INFORMATION HAS BEEN PROVIDED TO DETERMINE THE ROOT CAUSE OF THE PATIENT PAIN IN THIS CASE. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH PRODISC-L AT L4/L5 ON (B)(6) 2008. ON AN UNKNOWN POST-OPERATIVE DATE, PATIENT EXPERIENCED PAIN. X-RAYS SHOWED THAT THE SUPERIOR ENDPLATE ON THE PRODISC-L WAS BACKING OUT. PATIENT RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF PRODISC-L. PATIENT WAS REVISED WITH A COMPETITORS CAGE. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 1 OF 3 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126089 INFERIOR END PLATE MEDIUM-STERILE MJO SYNTHES BRANDYWINE 6344636

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention