BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASYS MIDLINE OCCIPUT PLATE ASSY MEDIUM

    MDR report key: 3120514 · Received May 20, 2013

    Report

    Report Number
    0009617544-2013-00193
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNI
    PMA / PMN Number
    K093670
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STRYKER SPINE HAS INITIATED A RECALL ON (B)(6) 2013 FOR OASYS MIDLINE OCCIPUT PLATES. THE 806 REPORT IS PENDING SUBMISSION.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, DEVICE HISTORY REVIEW, AND COMPLAINT HISTORY REVIEW. RESULTS: VISUAL INSPECTION: BOTH TULIPS ARE DETACHED FROM THE PLATE. THE PINS THAT HOLD THE TULIP ATTACHED TO THE PLATE BODY ARE BOTH BROKEN ON SIMILAR LOCATIONS. TULIPS THEMSELVES ARE NOT DAMAGED. FUNCTIONAL INSPECTION: NOT APPLICABLE. DEVICE BROKEN. DEVICE HISTORY REVIEW: BATCH#109932 MANUFACTURED ON 2010-JUL-30 AND COMPOSED OF 22 UNITS. NO ISSUES WERE REPORTED RELATED TO THIS COMPLAINT. COMPLAINT HISTORY: IN TOTAL THERE HAVE BEEN 8 CONFIRMED FAILED UNITS FOR PIN BREAKAGE WITH THIS PLATE. CONCLUSION: THE BREAKAGE OCCURRED ON BOTH PINS LINKING THE MULTI-AXIAL HEAD ONTO THE PLATE. THE MIDLINE PLATE HAS BEEN RETURNED, INSPECTED AND BOTH TULIP PINS CONFIRMED BROKEN. NO ANOMALY THAT COULD BE ASSOCIATED WITH THE EVENT WAS REPORTED DURING THE MANUFACTURING OF BATCHES 109932 (PLATE ASSEMBLY) OR 102315 (PIN). METALLURGICAL STRUCTURE IS CONFORMING TO SPECIFICATION. PIN BREAKAGES ARE THE RESULT OF A PROGRESSIVE CRACKING UNDER CYCLIC LOADING, FATIGUE THAT OCCURRED UNDER RELATIVELY LOW LOADING CONDITIONS. DESIGN VERIFICATION DATA ESTABLISHED AN AVERAGE MEAN ULTIMATE LOAD OF 2369N OF THE PIN UNDER CANTILEVER LOADS AT 1MM/MIN. A CAPA HAS BEEN OPENED TO FURTHER INVESTIGATE THE ISSUE. THE PIN BREAKAGE IS BELIEVED TO BE THE RESULT OF MULTIFACTORIAL CAUSES WHICH POTENTIALLY INCLUDE INSUFFICIENT MECHANICAL STRENGTH AND/OR EXTREME RELATIVE POSITIONING GENERATING OVERSTRESS. ADDITIONALLY, THESE DEVICES WERE REMOVED FROM THE FIELD ON (B)(4) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "PATIENT CAME IN WITH GRINDING SOUND IN NECK, X-RAYS EXPOSED BOTH SCREWS INTO OCCIPITAL PLATE BROKE. PLATE AND SCREWS REMOVED WITH MEDTRONIC IMPLANTS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "PATIENT CAME IN WITH GRINDING SOUND IN NECK, X-RAYS EXPOSED BOTH SCREWS INTO OCCIPITAL PLATE BROKE. PLATE AND SCREWS REMOVED WITH MEDTRONIC IMPLANTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221687 OASYS MIDLINE OCCIPUT PLATE ASSY MEDIUM IMPLANT MNI STRYKER SPINE-FRANCE 109932

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R