BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESA PEDICLE SCREW

    MDR report key: 2123114 · Received September 5, 2008

    Report

    Report Number
    3004774118-2008-00004
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 30, 2008
    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

    THE PARTS HAVE NOT YET BEEN RETURNED TO THE MFR FOR ANALYSIS. BROKEN PEDICLE SCREWS IS A WELL KNOWN COMPLICATION OF THIS PROCEDURE, ESPECIALLY IN THE SACRUM WHICH IS A REGION OF HIGH STRESS CONCENTRATION. THIS IS CAUTIONED IN THE PRODUCT INSERT. NO FIRM CONCLUSIONS CAN BE REACHED UNTIL THE DEVICES HAVE BEEN REC'D AND ANALYZED.

    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, MICROSCOPIC, CHEMICAL EVALUATION OF THE SUBJECT PART(S), K2M INC HAS DETERMINED THAT THE SCREW FRACTURE IS CONSISTENT WITH EXCESSIVE ANATOMIC LOADING. 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 MATERIAL, 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. REPORTEDLY, THE PATIENT IS CONTINUING TO DO WELL. A REVIEW OF ALL APPLICABLE RISK RELATED DOCUMENTS REVEALED THAT K2M ADDRESSES ALLEGED SCREW FRACTURE CONCERNS RAISED IN THIS COMPLAINT, 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

    BOTH S1 PEDICLE SCREWS FRACTURED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESA PEDICLE SCREW PEDICLE SCREW MNI K2M, INC Y38

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention