BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, NAIL

    MDR report key: 6516480 · Received April 24, 2017

    Report

    Report Number
    2520274-2017-11478
    Event Type
    Injury
    Date Received
    April 24, 2017
    Report Date
    March 28, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LEE, V., ET AL. (2004). EXTERNAL FIXATORS IN HAEMOPHILIA, HAEMOPHILIA (2004), 10, 52¿57. INDIA. THE STUDY OBJECTIVE WAS TO EVALUATE A VARIETY OF ORTHOPAEDIC PROBLEMS WITH EXTERNAL FIXATORS IN HAEMOPHILIC PATIENTS. 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. (B)(4). 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 LITERATURE ARTICLE: LEE, V., ET AL. (2004). EXTERNAL FIXATORS IN HAEMOPHILIA, HAEMOPHILIA (2004), 10, 52¿57. INDIA. THE STUDY OBJECTIVE WAS TO EVALUATE A VARIETY OF ORTHOPAEDIC PROBLEMS WITH EXTERNAL FIXATORS IN HAEMOPHILIC PATIENTS. THE CASE STUDY INCLUDED NINE PATIENTS, MEAN AGE: 19.2 YEARS; RANGE: 9¿37, SIX WITH SEVERE HAEMOPHILIA. TWO PATIENTS WITH MILD AND ONE WITH MODERATE HAEMOPHILIA A, WITH AN EXTERNAL FIXATOR FOR THE FOLLOWING INDICATIONS ¿ OPEN FRACTURES (FOUR), KNEE SEPTIC ARTHRITIS WITH GROSS ARTICULAR DESTRUCTION (TWO), OSTEOCLASIS OF MALUNITED FRACTURE (ONE), AND ARTHRODESIS OF KNEE (ONE), ANKLE (ONE). THE FOLLOWING EXTERNAL FIXATORS WERE USED ¿ CHARNLEY COMPRESSION CLAMP-2, AO PIN TYPE EXTERNAL FIXATOR-3 AND ILIZAROV TENSIONED WIRE FIXATOR- 4 (FEMUR-2, TIBIA-2). SEVEN OF NINE PATIENTS HAD THEIR FIXATOR REMOVED UNDER ONE DOSE FACTOR COVER AS AN OUTPATIENT WHILE IN ONLY ONE PATIENT THE ILIZAROV FIXATOR OF THE THIGH WAS REMOVED UNDER GENERAL ANAESTHESIA. FACTOR CONCENTRATES WERE REPLACED FOR HAEMOSTASIS BY INTERMITTENT BOLUS INJECTIONS IN SEVEN PATIENTS AND BY CONTINUOUS INFUSION IN TWO PATIENTS. FOR SURGERY, A LEVEL OF 80¿100% WAS ACHIEVED FOR HAEMOPHILIA A AND 60¿80% FOR HAEMOPHILIA B. SUBSEQUENTLY LOWER THAN USUALLY RECOMMENDED LEVELS WERE MAINTAINED POSTOPERATIVELY IN ALL THESE PATIENTS AIMING FOR 30¿40% BETWEEN DAYS 1 AND 3, 20¿30% BETWEEN DAYS 4 AND 6 AND 10¿20% THEREAFTER TILL SURGICAL WOUND HEALING. NO FACTOR REPLACEMENT WAS GIVEN PROPHYLACTICALLY AFTER THAT. IMPLANT REMOVAL WAS CARRIED OUT WITH A SINGLE DOSE OF FACTOR COVER AIMING FOR A LEVEL OF 40¿50%. THE FOLLOWING COMPLICATIONS WERE REPORTED: PATIENT SB, WHO PRESENTED AN OPEN FRACTURE TIBIA AND UNDERWENT A DEBRIDEMENT AND AO TYPE EXTERNAL FIXATOR WITH FOUR PIN TIBIA, RECEIVED AUTOLOGOUS BONE MARROW INJECTION AT LOCALLY TO PROMOTE BONE UNION UNDER ONE DOSE OF FACTOR COVER (25 IU KG) AT FOUR MONTHS. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN AO PIN TYPE EXTERNAL FIXATOR, UNKNOWN PART # / LOT #.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297935 APPLIANCE, FIXATION, NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention