BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5412481 · Received February 5, 2016

    Report

    Report Number
    2520274-2016-10790
    Event Type
    Injury
    Date Received
    February 5, 2016
    Report Date
    January 27, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS SMITH, CARLA S. MD. PHD, NORK, SEAN E MD AND SANGEORZAN, BRUCE J MD. (2006)."THE EXTRUDED TALUS: RESULTS OF REIMPLANTATION". THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED. VOLUME 88-A NUMBER 11 NOVEMBER 2006; UNITED STATES ARTICLE. THIS REPORT IS FOR UNKNOWN PLATE, UNKNOWN QUANTITY, UNKNOWN LOT. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, SMITH, CARLA S. MD. PHD, NORK, SEAN E MD AND SANGEORZAN, BRUCE J MD. (2006)."THE EXTRUDED TALUS: RESULTS OF REIMPLANTATION". THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED. VOLUME 88-A NUMBER 11 NOVEMBER 2006; UNITED STATES ARTICLE THE PURPOSE OF THE STUDE WAS TO REPORT THE CLINICAL RESULTS, COMPLICATIONS, AND FUNCTIONAL OUTCOME FOLLOWING REIMPLANTATION OF THE TRAUMATICALLY EXTRUDED TALUS. 27 PATIENTS WERE INITIALLY INCLUDED IN THE STUDY; A MINIMUM 1 YEAR FOLLOW UP OF 19 PATIENTS WAS OBTAINED. THE FOLLOWING COMPLICATIONS WERE NOTED: INFECTION; DEVELOPMENT OF ARTHRITIS, INCLUDING SCLEROSIS, JOINT-SPACE NARROWING OR OSTEOPHYTES; COLLAPSE OF THE TALUS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN MINI-FRAGMENT PLATE. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR 1 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71742 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention