BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERTION GUIDE

    MDR report key: 2925526 · Received January 22, 2013

    Report

    Report Number
    2520274-2013-00544
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 29, 2012
    Report Date
    December 31, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AWARENESS DATE WAS APPROXIMATELY ONE DAY AFTER REMOVAL SURGERY IN (B)(6) 2013. EXACT DATE UNKNOWN.

    Description of Event or Problem · 1

    PATIENT HAD ORIF PROXIMAL HUMERUS AND TFN PROCEDURES DONE CONCURRENTLY FOR MULTIPLE TRAUMA ON (B)(6) 2012. POSTOPERATIVELY, IT WAS NOTED THAT SURGEON HAD INADVERTENTLY IMPLANTED THE INSERTION GUIDE WITH THE PROXIMAL HUMERUS PLATE. REVISION WILL BE PERFORMED ON AN UNDETERMINED DATE TO REMOVE THE INSERTION GUIDE.

    Description of Event or Problem · 1

    ADDITIONAL SURGERY WAS PERFORMED ON AN UNKNOWN DATE IN (B)(6), 2013, APPROXIMATELY 6 WEEKS AFTER THE INITIAL SURGERY DATE ON (B)(6) 2012, TO REMOVE AN INSERTION GUIDE THAT WAS INADVERTENTLY LEFT IN THE PATIENT. INSERTION GUIDE WAS SUCCESSFULLY REMOVED, PATIENT WAS REPORTEDLY HEALING SATISFACTORILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30030 INSERTION GUIDE FZX SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention