BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE,FIXATION,NAIL

    MDR report key: 6523042 · Received April 26, 2017

    Report

    Report Number
    2520274-2017-11528
    Event Type
    Injury
    Date Received
    April 26, 2017
    Report Date
    March 31, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EMDAD HOSSAIN, NEERAJ DUGAR, ANANT KUMAR GARG, SANJAY KUMAR (2013). COMPARATIVE RESULTS OF TREATMENT OF OPEN DIAPHYSEAL FRACTURES OF TIBIA BY THE USE OF COMMONLY USED EXTERNAL FIXATORS. J INDIAN MED ASSOC, III, 830-832. THIS REPORT IS FOR UNKNOWN EXTERNAL FIXATOR WITH PINS, UNKNOWN QUANTITY, UNKNOWN LOT 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. 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

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: EMDAD HOSSAIN, NEERAJ DUGAR, ANANT KUMAR GARG, SANJAY KUMAR (2013). COMPARATIVE RESULTS OF TREATMENT OF OPEN DIAPHYSEAL FRACTURES OF TIBIA BY THE USE OF COMMONLY USED EXTERNAL FIXATORS. J INDIAN MED ASSOC, III, 830-832. A RETROSPECTIVE AND PROSPECTIVE STUDY WAS CONDUCTED TO INVESTIGATE THE OUTCOME OF TREATMENT USING AN EXTERNAL FIXATOR FOR TYPE IIIA AND IIIB FRACTURES SUSTAINED BY THE 45 PATIENTS (37 MALES, 8 FEMALES), MINIMUM AGE OF 14 YEARS, MAXIMUM AGE OF 58 WITH MEAN AGE OF 36. PATIENTS WERE FOLLOWED FOR 6 MONTHS UP TO 2 YEARS. NORMAL UNION COULD BE FOUND IN 25 PATIENTS. OF THE 45 PATIENTS A NUMBER EXPERIENCED COMPLICATIONS: (SI). ELEVEN PATIENTS EXPERIENCED DELAYED UNION (UNION AFTER 30 WEEKS). NINE PATIENTS EXPERIENCED A NON-UNION (NO UNION AFTER 9 MONTHS). TWELVE PATIENTS EXPERIENCED INFECTION. ELEVEN PATIENTS EXPERIENCED A MAL-UNION. SIXTEEN PATIENTS EXPERIENCES JOINT STIFFNESS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN AO EXTERNAL FIXATOR WITH PINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303978 APPLIANCE,FIXATION,NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention