BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, NAIL, FIXATION

    MDR report key: 6517223 · Received April 24, 2017

    Report

    Report Number
    2520274-2017-11484
    Event Type
    Injury
    Date Received
    April 24, 2017
    Report Date
    April 3, 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. LERNER, A., FODOR, L., SOUDRY, M., PELED,I.J., HERER, D., AND ULLMANN, Y. (2004) ACUTE SHORTENING: MODULAR TREATMENT MODALITY FOR SEVERE COMBINED BONE AND SOFT TISSUE LOSS OF THE EXTREMITIES. THE JOURNAL OF TRAUMA. INJURY, INFECTION AND CRITICAL CARE 57: 603-608. THIS REPORT IS FOR UNKNOWN AO/ASIF TUBULAR EXTERNAL FIXATION, 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.

    Additional Manufacturer Narrative · 1

    INCORRECTLY REPORTED ON INITIAL (B)(4); DATE SHOULD BE (B)(6) 2017. 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 ARTICLE IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, LERNER, A., FODOR, L., SOUDRY, M., PELED,I.J., HERER, D., AND ULLMANN, Y. (2004) ACUTE SHORTENING: MODULAR TREATMENT MODALITY FOR SEVERE COMBINED BONE AND SOFT TISSUE LOSS OF THE EXTREMITIES. THE JOURNAL OF TRAUMA. INJURY, INFECTION AND CRITICAL CARE 57: 603-608. TWELVE PATIENTS UNDERWENT ACUTE SHORTENING AND STABILIZATION USING THE ILIZAROV FRAME. NINE OF THEM UNDERWENT PROGRESSIVE LENGTHENING TO RESTORE THE LENGTH. FOR THREE PATIENTS, ANGULATION OF THE BONE SEGMENTS WAS PERFORMED TO SAVE THEM FROM EXCESSIVE BONE DEBRIDEMENT. ALL PATIENTS WERE MEN BETWEEN THE AGES OF 18 AND 33 YEARS, EXCEPT FOR ONE, WHO WAS (B)(6). EIGHT OF THEM SUSTAINED LOWER LIMB FRACTURES AND FOUR HAD UPPER LIMB FRAC- TURES. THE MEAN BONE LOSS WAS 7.9 CM (RANGE, 2.5¿22 CM). THE FRACTURED BONES WERE REALIGNED AND STABILIZED BY MEANS OF AO/ASIF TUBULAR EXTERNAL FIXATION FOLLOWED BY IMMEDIATE EXTENSIVE SOFT TISSUE DEBRIDEMENT AND CLEANSING. TWO PATIENTS EXPERIENCED ARTHRODESIS CAUSED BY EXTENSIVE DESTRUCTION OF THE JOINT SURFACES DURING PRIMARY TRAUMA. ONE PATIENT REQUIRED EXTENSIVE DEBRIDEMENT WITH ACUTE SHORTENING OF THE UPPER LIMB, LEAVING A FLAIL, FUNCTIONAL PSEUDOARTICULATION OF THE ELBOW WITH A HINGED EXTERNAL FIXATION DEVICE, SEVEN PATIENTS NEEDED A BONE-LENGTHENING PROCEDURE BY OSTEOGENESIS USING THE ILIZAROV TECHNIQUE AFTER ACUTE SHORTENING. ONE PATIENT NEEDED AN ADDITIONAL FREE ILIAC BONE GRAFT TO THE ULNA AND THE RADIUS. TWO PATIENTS NEEDED ELONGATION OSTEOTOMY AFTER ACUTE SHORTENING FOR THEIR LIMB LENGTH RESTORATION. IN TWO OF THREE PATIENTS WITH INITIAL TRAUMA, THE NERVE INJURY RESOLVED PARTIALLY DURING THE TIME OF FRACTURE CONSOLIDATION. EXTENSIVE SOFT TISSUE LOSS WAS NOTED PRIMARILY AMONG ALL THE PATIENTS. ONE PATIENT REQUIRED A FREE FLAP. FIVE PATIENTS EXPERIENCED A PIN-TRACT INFECTION WITHOUT INVOLVEMENT OF THE BONE . SOME PATIENTS EXPERIENCED PAIN AND DISCOMFORT. ONE PATIENT HAD LEG LENGTH DISCREPANCY. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN AO/ASIF TUBULAR EXTERNAL FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297458 APPLIANCE, NAIL, FIXATION KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention