BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACTION,APPARATUS,NON-POWERED

    MDR report key: 6653236 · Received June 20, 2017

    Report

    Report Number
    2520274-2017-11824
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    July 9, 2016
    Report Date
    June 5, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HST
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN - DISTRACTOR ASSEMBLY (ADJUSTABLE-VECTOR ALVEOLAR RIDGE DISTRACTOR AND/OR MULTI-VECTOR DISTRACTOR)/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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE LU, T. AND ET AL. (2016) SIMULTANEOUS MAXILLO-MANDIBULAR DISTRACTION IN EARLY ADOLESCENCE AS A SINGLE TREATMENT MODALITY FOR DURABLE CORRECTION OF TYPE II UNILATERAL HEMIFACIAL MICROSOMIA: FOLLOW-UP TILL COMPLETION OF GROWTH. JOURNAL OF CRANIO-MAXILLO-FACIAL SURGERY, VOLUME 44: 1201-1208. THE PURPOSE OF THIS ARTICLE WAS TO PRESENT FAVORABLE EXPERIENCE USING SINGLE-TREATMENT SIMULTANEOUS MAXILLO-MANDIBULAR DISTRACTION IN EARLY ADOLESCENT PRUZANSKYEKABAN TYPE II HEMIFACIAL MICROSOMIA (HFM) PATIENTS. THIS RETROSPECTIVE STUDY OCCURRED BETWEEN 2007-2012. THE STUDY INCLUDE SEVEN (7) PATIENTS WITH CONSECUTIVE TYPE IIA/B HFM TREATED WITH SIMULTANEOUS MAXILLO-MANDIBULAR DISTRACTION. THERE WERE FOUR (4) FEMALES AND THREE (3) MALES BETWEEN THE AGES OF 12 TO 16 YEARS (AVERAGE 13.7 YEARS). THE MEAN FOLLOW-UP TIME WAS 4.9 YEARS (RANGE: 3-7 YEARS). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN - DISTRACTOR ASSEMBLY (ADJUSTABLE-VECTOR ALVEOLAR RIDGE DISTRACTOR AND/OR MULTI-VECTOR DISTRACTOR) AND REFERS TO PATIENT 6 (FEMALE, (B)(6)) WHO HAD MILD PIN-TRACT INFECTION AND LOOSENING TREATED CONSERVATIVELY WITH ANTIBIOTICS UNTIL COMPLETION OF DISTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433847 TRACTION,APPARATUS,NON-POWERED HST SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention