BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALEUTIAN INTERBODY

    MDR report key: 2031606 · Received March 23, 2011

    Report

    Report Number
    3004774118-2011-00005
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 22, 2011
    Manufacturer
    K2M, INC.
    Product Code
    MAX
    PMA / PMN Number
    K082698
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT CAUSE OF EXPULSION UNK; HOWEVER, SURGICAL TECHNIQUE SUGGESTED TO BE A POTENTIAL CONTRIBUTORY FACTOR.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT WAS RETURNED FOR EVALUATION AND EVALUATION HAS BEEN COMPLETED. UPON VISUAL AND FUNCTIONAL EVALUATION OF THE SUBJECT PART(S), IT WAS FOUND THAT THE EXACT CAUSE OF CAGE BACKOUT COULD NOT BE ASCERTAINED. ACCORDING TO THE APPLICABLE PRODUCT LINE RISK RELATED DOCUMENTS, K2M HAS IDENTIFIED THAT THE CAGE MAY HAVE BACKED OUT DUE TO INCORRECT SIZE, MISPLACEMENT, SURGICAL TECHNIQUE. THE SURGEON FELT IT WAS POSSIBLE THAT THE CASE WAS NOT ADEQUATELY PLACED DUE TO THE DIFFERENCE IN THE TOOTH PATTERN COMPARED TO THE PATTERN HE IS ACCUSTOMED TO UTILIZING. A REVIEW OF ALL APPLICABLE INSPECTION AND MANUFACTURING RECORDS ACCORDING TO THE DESCRIPTION OF THE PRODUCTS USED WITH THE CONCOMITANT DEVICE(S) WAS CONDUCTED. ALL RECORDS REVEALED THAT ALL PRODUCTS LOTS WERE MANUFACTURED WITHIN SPECIFICATIONS AND DISTRIBUTED IN ACCORDANCE WITH ALL OPERATING PROCEDURES. A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS DID NOT REVEAL ANY CONTRIBUTING INFORMATION/TRENDS. A REVIEW OF THE COMPLAINT CODE TRENDS DID NOT REVEAL ANY CONTRIBUTING INFORMATION AS TO THE CAUSE OF THIS EVENT. A REVIEW OF ALL APPLICABLE RISK RELATED DOCUMENTS REVEALED THAT K2M ADDRESSES ALLEGED CAGE BACKOUT CONCERNS RAISED IN THIS INCIDENT, THEREFORE NO ADDITIONAL HAZARDS REQUIRED. CURRENT SEVERITY AND FREQUENCY VALUES ARE SATISFACTORY AND NO CHANGES ARE DEEMED NECESSARY. A REVIEW OF THE SURGICAL TECHNIQUE GUIDE AND IFU ARE ACCURATE AND AVAILABLE TO THE SURGEON - NO EDITS ARE DEEMED NECESSARY BASED ON THE INFORMATION PROVIDED IN REGARDS TO THIS EVENT.

    Description of Event or Problem · 1

    PT REPORTEDLY HEARD A POP AND FELT IMMEDIATE PAIN 3 WEEKS POST-OPERATIVELY. INTERBODY HAD REPORTEDLY DISLODGED AND HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALEUTIAN INTERBODY CERVICAL INTERBODY MAX K2M, INC. JBX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention