BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 1970051 · Received January 25, 2011

    Report

    Report Number
    1030489-2011-00070
    Event Type
    Injury
    Date Received
    January 25, 2011
    Report Date
    May 11, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: THE DEVICE WAS EXPLANTED AFTER 7 YEARS IN VIVO. THE NOMINAL HEIGHT LOSS WAS 1.7 MM, AND DID NOT FALL WITHIN THE MANUFACTURING TOLERANCES FOR THE COMPONENT. THE MECHANISM OF THE HEIGHT LOSS, WHETHER CREEP OR WEAR OR A COMBINATION OF THE TWO, REMAINS UNCLEAR WITHOUT FURTHER ANALYSIS. WE FOUND EVIDENCE OF CHRONIC IMPINGEMENT OF THE TOTAL DISC REPLACEMENT COMPONENTS BASED ON THE FLATTENING OF THE NUCLEUS AROUND THE RIM. WE ALSO FOUND NO EVIDENCE OF DAMAGE THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT COMPONENTS. FTIR ANALYSIS DID NOT DETECT CHEMICAL CHANGES TO THE CORE IN VIVO.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. REVIEW OF MULTIPLE SAGITTAL RECONSTRUCTION CT IMAGES OF (B)(6) WAS PERFORMED. REMOVAL FILMS PROVIDED WITH LAYER DEFECT AT LOCATION OF PREVIOUS IMPLANT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS A PATIENT WITH PERIPROSTHETIC OSTEOLYSIS 6 YEARS AND 9 MONTHS AFTER THE INSERTION OF A BRYAN DISC. THE OSTEOLYSIS IS ONLY LOCATED AT THE LEFT SIDE OF THE PROSTHESIS. THIS NOW (B)(6) PATIENT REPORTED NECK PAIN ON THE RIGHT SIDE IRRADIATING TOWARD HIS RIGHT SHOULDER AND RIGHT UPPER ARM IN COMBINATION WITH LEFT SIDED PARESTHESIAS IN HIS HAND AND THUMB. PLAIN FILMS SHOW A NARROWING OF THE PROSTHESIS IN COMPARISON TO THE SITUATION 3 AND 6 YEARS AGO. CT SHOWS OSTEOLYSIS AT THE LEFT SIDE OF THE PROSTHESIS WITH SOME REACTIVE BONE REMODELING AND POSSIBLY SOME SOFT TISSUE EXTENDING IN THE LEFT FORAMEN C5-6. IN ADDITION TO THAT, HE DEVELOPED SEVERE RIGHT SIDED FACETARTROSIS AT C2-3 AND C3-4, WHICH WAS NOT THERE AT THE PREOP CT-SCAN OF 2004. IN THE SUPERIOR ARTICULAR PROCESS OF C4 THERE IS A RADIOLUCENCY, PROBABLY CORRESPONDING WITH AN ARTHROTIC GEODE. SURGEON BELIEVES THAT THE NECK- AND RIGHT SIDED ARM PAIN ARE DUE TO THE FACETARTHROSIS WHEREAS THE PARESTHESIAS IN THE LEFT HAND ARE CORRELATED WITH THE NARROWING OF THE INTERVERTEBRAL FORAMEN AT C5-6. THE SURGEON HAS SCHEDULED AN ADDITIONAL MRI-SCAN AND EMG, WHICH WILL BE DONE IN A FEW DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRYAN CERVICAL DISC SYSTEM MJO WARSAW ORTHOPEDIC, INC. 136-03128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other