BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR C 8 X 12 X 14 X 4DEG. CERVICAL STD ALONE CAGE

    MDR report key: 3013401 · Received March 20, 2013

    Report

    Report Number
    3005525032-2013-00027
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    OVE
    PMA / PMN Number
    K102606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ANCHOR C CAGE WAS REPORTED HAVING ITS TITANIUM PLATE AND PEEK SPACER SEPARATED WHILE THE SURGEON REMOVED IT FROM DISC SPACE FOR REPOSITIONING. THE IMPLANT WAS RETURNED, INSPECTED AND CONFIRMED DISASSEMBLED. THE DISASSEMBLED PEEK SPACER HAS OBVIOUS DEFORMATIONS/BREAKAGES MOST PROBABLY RESULTING FROM A LATERAL IMPACTION MADE WHILE TRYING TO READJUST THE CAGE POSITION PRIOR TO ITS REMOVAL. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AS NO INDICATION OF MATERIAL OR MANUFACTURING DEFECT COULD BE FOUND. BASED ON THE OBSERVATIONS MADE DURING THE INVESTIGATION, THE SEPARATION OF THE COMPONENTS IS BELIEVED TO BE THE RESULT OF THE DAMAGES MADE WHILE READJUSTING THE CAGE POSITION. THUS, THE COMPLAINT CONDITION IS RELATED TO THE CONDITIONS OF USE AND THE OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "SURGEON WAS PLACING THE IMPLANT INTO THE DISC SPACE AND WHEN HE DECIDED TO ADJUST IT, HE PULLED ON THE IMPLANT TO REMOVE IT AND THE TITANIUM PLATE SEPARATED FROM THE PEEK SLIGHT DELAY OF ABOUT 10MIN".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "SURGEON WAS PLACING THE IMPLANT INTO THE DISC SPACE AND WHEN HE DECIDED TO ADJUST IT, HE PULLED ON THE IMPLANT TO REMOVE IT AND THE TITANIUM PLATE SEPARATED FROM THE PEEK. SLIGHT DELAY OF ABOUT 10MIN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116152 ANCHOR C 8 X 12 X 14 X 4DEG. CERVICAL STD ALONE CAGE AVS® ANCHOR-C CERVICAL CAGE 8MM X 12MM X14MM X 4° OVE STRYKER SPINE-SWITZERLAND B21673

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR