BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGA21 SELFTAPPING SCREW 6 35X50MM

    MDR report key: 2874203 · Received December 14, 2012

    Report

    Report Number
    0009610576-2012-00027
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    MNI
    PMA / PMN Number
    PK031354
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. (B)(4). THIS IS 1 OF 4 MDR REPORTS FOR THE SAME EVENT (SEE: 0009610576-2012-00027 / 30).

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR ACTUAL PRODUCT EVALUATION. MANUFACTURING HISTORY WAS REVIEWED SHOWING NO NON-CONFORMITY, REJECTION OR CONCESSION. 100% OF THE PIECES WERE ACCEPTED IN THE MANUFACTURING ORDER. NO SIMILAR COMPLAINTS FOR THIS ITEM/LOT NUMBER HAVE BEEN RECEIVED, NOR FOR ANY OTHER ITEMS REGARDING THIS TYPE OF EVENT. THE PURPOSE OF SPINAL IMPLANTS IS TO PROVIDE SHORT TERM STABILITY WHILE ARTHRODESIS TAKES PLACE. LITERATURE CLINICAL DATA ESTABLISHES THAT THE AVERAGE TIME UNTIL FUSION IS 12 MONTHS. ACCORDING TO THE INFORMATION PROVIDED BY THE SALES REPRESENTATIVE, THE SCREWS HAD BEEN IMPLANTED FOR ALMOST THREE YEARS AND THE FUSION WAS NOT CONSOLIDATED. AN UNSUCCESSFULLY CONSOLIDATED FUSION COULD BE RELATED TO THE BREAKAGE OF THE SCREWS FUR TO THE FACT THAT THE PERIOD OF TIME IN WHICH THE SCREWS WERE SUBJECTED TO LOADS IS GREATER THAN IN THE CASES IN WHICH FUSION IS FULLY CONSOLIDATED. NO EVIDENCE WAS FOUND THAT RELATED THE REPORTED EVENT TO THE RAW MATERIALS, MANUFACTURING OR INSPECTION PROCESS OF THE AFFECTED DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY SPINAL SURGERY 2-3 YEARS AGO. REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2012 DUE TO BROKEN SCREWS IN THE DORSAL AND VENTRAL AREAS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMEGA21 SELFTAPPING SCREW 6 35X50MM OMEGA 21 SPINAL FIXATION SCREW MNI BIOMET SPAIN, S.L. N/A 2009010944

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R