BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRENEES CERVIAL PLATE

    MDR report key: 2003621 · Received February 23, 2011

    Report

    Report Number
    3004774118-2011-00003
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 15, 2011
    Report Date
    January 18, 2011
    Manufacturer
    K2M, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K060442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND A THOROUGH INVESTIGATION COULD NOT BE COMPLETED AS NO LOT NUMBER HAS BEEN IDENTIFIED/CONFIRMED IN THIS CASE. SINCE THE PLATE REMAINS WITH THE HOSPITAL, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED. A REVIEW OF APPLICABLE INSPECTION AND MANUFACTURING RECORDS OF POSSIBLE DEVICE MANUFACTURING DATES 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. ACCORDING TO THE APPLICABLE PRODUCT LINE RISK RELATED DOCUMENTS, K2M HAS IDENTIFIED THAT THE PLATE MAY HAVE FAILED DUE TO NON-UNION, MISPLACEMENT, SURGICAL TECHNIQUE. SEVERAL OTHER CAUSES WHICH MAY HAVE BEEN CONTRIBUTED TO THIS ISSUE COULD BE EXCESSIVE FORCE/TRAUMA, INAPPROPRIATE ACTIVITY DURING RECOVERY AS IDENTIFIED IN THE IFU. A REVIEW OF ALL APPLICABLE RISK RELATED DOCUMENTS REVEALED THAT K2M ADDRESSES POTENTIAL FRACTURE CONCERNS RAISED IN THIS COMPLAINT, THEREFORE NO ADDITIONAL HAZARDS REQUIRED. CURRENT SEVERITY AND FREQUENCY VALUES ARE SATISFACTORY AND NO CHANGES ARE DEEMED NECESSARY.

    Additional Manufacturer Narrative · 1

    THE PLATE WAS RETRIEVED AND RETAINED BY THE PATHOLOGY LABORATORY AT THE HOSPITAL. EFFORTS ARE UNDERWAY TO OBTAIN IT FOR EVALUATION.

    Description of Event or Problem · 1

    SURGEON NOTICED BROKEN 2-LEVEL PLATE DURING THE 3-MONTH FOLLOW-UP VISIT. THE PATIENT WAS NEUROLOGICALLY INTACT AND EXPERIENCING NO PAIN, HOWEVER, THE SURGEON DID PERFORM REVISION SURGERY TO REMOVE AND REPLACE THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PYRENEES CERVIAL PLATE CERVICAL PLATE KWQ K2M, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention