BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGA21 EXPANSIVE SCREW 7X35MM

    MDR report key: 3483805 · Received November 22, 2013

    Report

    Report Number
    0009610576-2013-00021
    Event Type
    Injury
    Date Received
    November 22, 2013
    Date of Event
    October 23, 2013
    Report Date
    October 24, 2013
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    MNI
    PMA / PMN Number
    PK992333
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE ITEMS WILL NOT BE RETURNED FOR EVALUATION SO NO PRODUCT INVESTIGATION CAN BE PERFORMED AND NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. ITEM HAS NOT BEEN RETURNED TO THE MANUFACTURER. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EXPIRATION DATE - UNKNOWN. IMPLANT DATE - 2010 (EXACT DATE UNKNOWN). REPORTER NAME - UNKNOWN. MANUFACTURE DATE - UNKNOWN. DEVICE IS EXPECTED TO BE RETURNED. UPON ITEM RETURN AND COMPLETION OF EVALUATION, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. THIS IS 1 OF 2 MDR REPORTS SUBMITTED FOR THE SAME EVENT - SEE: 9610576-2013-00021 / 22.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY SPINE SURGERY IN 2010. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PAIN AND FRACTURED SCREW HEADS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608231 OMEGA21 EXPANSIVE SCREW 7X35MM ORTHOSIS, SPINAL PEDICLE FIXATION MNI BIOMET SPAIN, S.L. N/A 04075984

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R