BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVS ARIA 8DEGX22X55X10 CAGE

    MDR report key: 2896440 · Received December 28, 2012

    Report

    Report Number
    9617544-2012-00616
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MAX
    PMA / PMN Number
    K101051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, MFG RECORD REVIEW, COMPLAINT HISTORY ANALYSIS, LABELING REVIEW AND RISK ASSESSMENT. RESULTS: AFTER VISUAL INSPECTION THE RETURNED CAGE WAS FOUND TO BE SEVERELY DAMAGED. MFG RECORD REVIEW: NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE BREAKAGE WERE REPORTED DURING THE MFG. COMPLAINT HISTORY ANALYSIS: 14 PREVIOUS RECORDS HAVE BEEN REC'D. THE INVESTIGATIONS INTO PAST COMPLAINTS CONCLUDED THAT THE FAILURES WERE THE RESULT OF CANTILEVER FORCES BEING APPLIED TO THE ARIA IMPLANT INSERTER DURING INSERTION AND/OR THE IMPLANT NOT BEING CORRECTLY LOADED TO THE IMPLANT INSERTER. LABELING REVIEW: ARIA SURGICAL TECHNIQUE RECOMMENDS TO "GENTLY AND PROGRESSIVELY INSERT THE AVS ARIA IMPLANT INTO THE PREPARED DISC SPACE BY APPLYING CONTROLLED AND LIGHT HAMMERING ON THE IMPLANT INSERTER HANDLE". RISK ASSESSMENT: THE REPORTED EVENT RESULTED IN A DELAY IN SURGERY OF 2.5 HRS AND A SECOND SURGICAL. CONCLUSION: THE CAGE FAILURE IS BELIEVED TO BE THE RESULT OF USER-ERROR.

    Description of Event or Problem · 1

    UPON INSERTION AT L3-4 THE CAGE WAS IMPLANTED USING THE CUSTOMER INSERTER. THE CAGE WAS PLACED 3/4 OF THE WAY IN THE DISC SPACE AND THE THREADED PART OF THE CAGE WHICH ATTACHES TO THE INSERTER SHATTERED. THE CAGE COULD NOT BACK OUR OR ADVANCE. HE USED DRILLS TO BURR THE CAGE OUT, ONCE HE DID THAT AND REMOVED THE BROKEN CAGE HE TRIED ANOTHER CAGE OF THE SAME SIZE AND SAME INSERTER AND AGAIN THE SAME THING HAPPENED. IMPLANT BROKE UPON INSERTER AND WAS NOT FULLY SEATED IN THE DISC SPACE. THE CAGE WAS IMPACTED TOO FAR AND THE IMPLANT WENT THROUGH THE DISC SPACE. THE PT HAD TO BE FLIPPED TO RETRIEVE IT FROM THE OTHER SIDE. A SMALLER CAGE SIZE WAS INSERTED WITH THE OLD INSERTER WITH NO ISSUES OR COMPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVS ARIA 8DEGX22X55X10 CAGE IMPANT MAX STRYKER SPINE BORDEAUX NA SDV

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention SPECIALTY INSERTER