BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARRAY TITATNIUM IMPLANTS, SCREW

    MDR report key: 1354283 · Received March 31, 2009

    Report

    Report Number
    2242816-2009-00018
    Event Type
    Injury
    Date Received
    March 31, 2009
    Date of Event
    July 18, 2008
    Report Date
    March 26, 2009
    Manufacturer
    EBI, L.P.
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NO. 582710. THE SCREW THAT BROKE IS NOT KNOWN AT THIS TIME. THERE WAS A QUANTITY OF TWO OF CATALOG NO. 94635. MANUFACTURING DATE FOR PART IS NOT AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PARTS RETURNED TO MANUFACTURER FOR EVALUATION WERE:PART NO. LOT NO. 94635 313070

    Additional Manufacturer Narrative · 1

    FRACTURE ANALYSIS INDICATES SCREW SHAFT EXPERIENCED TORSIONAL OR BENDING FATIGUE OVERLOAD RESULTING IN SHAFT FRACTURE. ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    SCREWS BROKE IN THE NECK AND REVISION SURGERY HAD TO BE COMPLETED. PATIENT OUTCOME: NO ADVERSE EFFECT ON THE PATIENT REPORTED AT THE CONCLUSION OF THE REVISION SURGERY.

    Description of Event or Problem · 1

    IN 2009, A DOCTOR REPORTED TO ORMCO CORPORATION THAT FIVE DIFFERENT PATIENTS EXPERIENCED ENAMEL LOSS WHEN 5 DAMON3MX BRACKETS DEBONDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY TITATNIUM IMPLANTS, SCREW MNI EBI, L.P. 313070

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention