BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM TI CANN MATRIX POLYAXIALSCREW 40MM

    MDR report key: 2820429 · Received November 6, 2012

    Report

    Report Number
    2520274-2012-02906
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 9, 2012
    Product Code
    DZL
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A BROKEN SCREW HEAD. THE PATIENT UNDERWENT A TLIF PROCEDURE, L5 - S1, (B)(6) 2011. A ROUTINE, FOLLOW-UP, POST OPERATIVE X-RAY REVEALED THAT THE HEAD OF A SCREW HAD BROKEN OFF. THE PATIENT HAS BEEN ASYMPTOMATIC. NO PLANS FOR REVISION OR OTHER TREATMENT HAVE BEEN IDENTIFIED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI CANN MATRIX POLYAXIALSCREW 40MM POLYAXIAL SCREW DZL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR