BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI CORTEX SCREW SLF-TPNGWITH T8 STARDRIVE RECESS 12MM

    MDR report key: 3091462 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02340
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LOT#: ACCORDING TO THE MANUFACTURING EVALUATION, THE LOT NUMBER ON THE SCREW WAS NOTED TO BE 7925463. ACCORDING TO THE MANUFACTURING EVALUATION, THE DEVICE WAS MANUFACTURED ON 05/25/2012. A MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES PART NUMBER 401.764 AND LOT NUMBER 7925463 ARE MARKED ON THE SCREW HEAD. NO VISIBLE DAMAGES, EXCEPT SOME SIGNS OF USE. THE MANUFACTURING DOCUMENTS FOR PART NUMBER 401.764 AND LOT NUMBER 7925463 WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE DETECTED. THIS SCREW WAS MANUFACTURED ON 05/25/2012 ACCORDING TO THE SPECIFICATION. THE RELEVANT DIMENSIONS WERE CHECKED AND NO DEVIATION WAS FOUND. NO MANUFACTURING RELATED FAULT COULD BE DETECTED. PLACEHOLDER

    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 COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A VOLAR PLATE WAS IMPLANTED ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, THE PLATE PULLED AWAY FROM THE BONE CAUSING THE PATIENT PAIN. THE SURGEON PERFORMED A HARDWARE REMOVAL OF THE PLATE AND SEVEN SCREWS ON (B)(6) 2013. A LARGER PLATE AND NINE SCREWS WERE IMPLANTED INSTEAD. THE SURGEON REPORTED STRONGER FIXATION WITH THE NEW HARDWARE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 8 OF 8 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194847 2.4MM TI CORTEX SCREW SLF-TPNGWITH T8 STARDRIVE RECESS 12MM HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention