BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFERIOR END PLATE MEDIUM-STERILE

    MDR report key: 3113012 · Received May 15, 2013

    Report

    Report Number
    2530088-2013-00800
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 17, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORTEDLY THE PATIENT WAS IMPLANTED WITH PRODISC-L IN 2008, DATE UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS FOR PDL-M-IP00S AND THE RAW MATERIAL (COCRMORI40.00) INDICATE THERE WERE NO MANUFACTURING DISCREPANCIES RELEVANT TO THIS COMPLAINT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE RISK ANALYSIS WAS REVIEWED FOR PRODISC-L. THE CURRENT DESIGN CONTROLS INCLUDE: ENDPLATE FOOTPRINTS DESIGNED TO PROVIDE MAXIMUM VERTEBRAL ENDPLATE COVERAGE, SURGEON TRAINING FOR APPROPRIATE SIZING, PATIENT SELECTION AND INSTRUCTIONS FOR USE (OSTEOPOROSIS, OSTEOPENIA, OSTEOMALACIA ARE CONTRAINDICATIONS), TECHNIQUE GUIDE WARNS AGAINST EXCESSIVE BONY REMODELING, AND SUBSIDENCE IS DETECTABLE ON POST-OPERATIVE IMAGING. THE SEVERITY OF HARM IN THIS CASE, ASSOCIATED WITH A REOPERATION OF THE PATIENT, IS CONSISTENT WITH THAT COVERED BY THE CURRENT RISK ANALYSIS DOCUMENT. A JOURNAL REVIEW WAS ALSO CONDUCTED TO EVALUATE ARTICLES WITH RELEVANCE TO THE CURRENT COMPLAINT. THE CAUSE OF THE SUBSIDENCE IN THIS CASE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED. POTENTIAL CAUSES FOR THE SUBSIDENCE INDICATED IN THE LITERATURE COULD INCLUDE POOR BONE DENSITY (OSTEOPENIA OR OSTEOPOROSIS), ENDPLATE SIZING, AND ENDPLATE MORPHOLOGY AND PREPARATION.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH PRODISC-L ON AN UNKNOWN DATE IN 2008. REPORTEDLY THE SUPERIOR ENDPLATE OF THE PRODISC-L SUBSIDED AT L4 POST-OPERATIVELY. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REVISION SURGERY. THE HARDWARE WAS REMOVED AND THE PATIENT WAS REVISED TO A FUSION AT THE REVISION LEVEL. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214726 INFERIOR END PLATE MEDIUM-STERILE MJO SYNTHES BRANDYWINE 5329896

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention