BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE,FIXATION,NAIL

    MDR report key: 5608740 · Received April 26, 2016

    Report

    Report Number
    2520274-2016-12270
    Event Type
    Injury
    Date Received
    April 26, 2016
    Report Date
    April 20, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. HUANG, T. AND ET AL. (2005) OPERATIVE TREATMENT OF INTRA-ARTICULAR DISTAL RADIUS FRACTURES USING THE SMALL AO EXTERNAL FIXATION DEVICE. J CHIN MED ASSOC, VOLUME 68(10): 474-478. THIS REPORT IS FOR UNKNOWN ¿ SMALL AO EXTERNAL FIXATOR/UNKNOWN QUANTITY/UNKNOWN LOT. (OTHER NUMBER) 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 LITERATURE ARTICLE HUANG, T. AND ET AL. (2005) OPERATIVE TREATMENT OF INTRA-ARTICULAR DISTAL RADIUS FRACTURES USING THE SMALL AO EXTERNAL FIXATION DEVICE. J CHIN MED ASSOC, VOLUME 68(10): 474-478. THE PURPOSE OF THIS ARTICLE IS TO EVALUATE THE EFFECT OF THE SMALL AO EXTERNAL FIXATOR IN THE MANAGEMENT OF ACUTE INTRA-ARTICULAR FRACTURES OF THE DISTAL RADIUS. THIS WAS A RETROSPECTIVE STUDY THAT OCCURRED BETWEEN (B)(6) 1995 AND (B)(6) 1996. THE STUDY INVOLVED EIGHTY-THREE (83) PATIENTS, OF WHICH SIX (6) PATIENTS DIED AND SEVEN (7) CASES WERE LOST TO FOLLOWING-UP, THEREFORE, SEVENTY (70) PATIENTS WERE IN THE FINAL EVALUATION. THERE WAS A TOTAL OF THIRTY-ONE (31) MALES AND THIRTY-NINE (39) FEMALES WITH A MEAN AGE OF 58.9 YEARS (RANGE, 14-87 YEARS). THE MEAN FOLLOW-UP PERIOD WAS 104 MONTHS (RANGE, 92-118 MONTHS). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN - SMALL AO EXTERNAL FIXATOR PLATE AND REFERS TO THREE (3) UNKNOWN PATIENTS WHO HAD IRRITATION OF THE SUPERFICIAL BRANCH OF THE RADIAL NERVE THAT RESOLVED AFTER REMOVAL OF EXTERNAL FIXATION, ONE (1) UNKNOWN PATIENT WHO HAD LOSS OF REDUCTION, THREE (3) UNKNOWN PATIENTS WHO HAD PIN-TRACT INFECTION THAT WAS TREATED WITH ANTIBIOTIC TREATMENT AND SYMPTOMS WERE RESOLVED AFTER PIN REMOVAL, AND ONE (1) UNKNOWN PATIENT WHO WITH REFLEX SYMPATHETIC DYSTROPHY WHICH RESOLVED WITH PHYSICAL THERAPY AFTER REMOVAL OF THE FIXATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263937 APPLIANCE,FIXATION,NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention