BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 3013173 · Received March 20, 2013

    Report

    Report Number
    2520274-2013-01571
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 26, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH MATRIX POSTERIOR FUSION ON (B)(6) 2012. SURGEON USED A TOTAL OF 18 HOOKS AND SCREWS FOR THIS CONSTRUCT. POST-OPERATIVE X-RAYS SHOWED THAT ONE POLYAXIAL HEAD WAS DISLODGED FROM THE SCREW SHAFT ON L5, AND A LOCKING CAP WAS DISLODGED FROM S1 ON THE SCREW HEAD. THIS LOCKING CAP WAS ANGLED AND NOT FLUSH WITH THE ROD. PATIENT WAS SCHEDULED FOR REVISION SURGERY, WHICH WILL TAKE PLACE ON AN UNKNOWN DATE. THIS IS 2 OF 3 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT IS #2 OF 3 FOR THE SAME EVENT REPORTED UNDER COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115254 TI MATRIX LOCKING CAP MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention