BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESA PEDICLE SCREW

    MDR report key: 2023314 · Received February 15, 2011

    Report

    Report Number
    3004774118-2011-00004
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 8, 2010
    Report Date
    March 7, 2011
    Manufacturer
    K2M, INC.
    Product Code
    MNI
    PMA / PMN Number
    K052398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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 SCREW FRACTURING WAS DUE TO FATIGUE OVERLOAD BY REVERSE BENDING. 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 SCREW FRACTURE 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXAMINED AND FOUND TO BE WITHIN SPECIFICATION. IT WAS SUBSEQUENTLY SENT TO AN INDEPENDENT LABORATORY FOR ANALYSIS; HOWEVER, THE EVAL IS STILL ONGOING, SO NO FIRM CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ONE 8.5 MM PEDICLE SCREW FRACTURED AT THE NECK. THE SURGEON THOUGHT THE SCREW MIGHT HAVE BEEN LEFT A LITTLE PROUD, CAUSING IT TO SNAP. REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESA PEDICLE SCREW PEDICLE SCREW MNI K2M, INC. I26

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention