BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02916

    MDR report key: 3142335 · Received June 3, 2013

    Report

    Report Number
    2520274-2013-02916
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 7, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE 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 INFORMATION: PATIENT ID - CASE #: (B)(6). IMPLANT DATE WAS REPORTED AS APPROXIMATELY 12 YEARS PRIOR TO DATE OF EXPLANT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEFT WRIST PLATE WAS EXPLANTED DUE TO A RUPTURED TENDON. THE FRACTURE FOR WHICH IT WAS IMPLANTED HAD FULLY HEALED SO NO REVISION WAS NECESSARY. THE PLATE WAS CUT TO FACILITATE THE REMOVAL OF A SCREW, WHICH BROKE AND WAS SUBSEQUENTLY LEFT IN THE PATIENT. THE DIFFICULTY IN REMOVING THE PLATE EXTENDED THE PROCEDURE BY ONE AND A HALF HOURS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243311 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention