BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN(R) TITANIUM MID-SECTION

    MDR report key: 2892526 · Received January 2, 2013

    Report

    Report Number
    1043534-2012-01735
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 28, 2012
    Report Date
    November 29, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. PHOTOGRAPHIC IMAGES WERE MADE OF THE PRODUCT. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS PRODUCT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-01736, 01737, 01738, 01739, 01740.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT HAD AMPUTATION 1 YR POST-OP UNRELATED TO THE PRODUCT. THE EXPLANTED PROXIMAL 2/3 OF THE TIBIA WAS SENT TO LOOK AT THE BONE INGROWTH (FOR EDUCATIONAL PURPOSES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977 GUARDIAN(R) TITANIUM MID-SECTION CUSTOM COMPONENT, CODE:KRO KRO WRIGHT MEDICAL TECHNOLOGY, INC. 1396718

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention