BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 3081884 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-11150
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    January 6, 2012
    Report Date
    January 6, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. 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

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(6) 2012.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A MATRIX CONSTRUCT ON (B)(6) 2012. POST OPERATIVE X-RAY SHOWED ONE SCREW WAS NOT IN PROPER PLACEMENT. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012. THE SCREW WAS REMOVED AND REPLACED WITH A HOOK. DURING THE REMOVAL THE TIP OF THE SPORT GRIP STARDRIVE SHAFT FOR MATRIX BROKE WHILE TAKING OUT THE LOCKING CAP. SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. THIS IS 2 OF 2 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183539 TI MATRIX LOCKING CAP NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention