BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANDIBULAR DISTRACTION DEVICES

    MDR report key: 4198108 · Received October 23, 2014

    Report

    Report Number
    2520274-2014-13976
    Event Type
    Injury
    Date Received
    October 23, 2014
    Report Date
    September 29, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NECROTIZING SOFT TISSUE INFECTION OF THE SCALP AFTER FRONTO-FACIAL ADVANCEMENT BY INTERNAL DISTRACTION IN A (B)(6) YEAR OLD GIRL WITH GORLIN CHAUDHRY MOSS SYNDROME E A CASE REPORT ADOLPHS N., KLEIN M., HABERL E., GRAUL-NEUMANN L., MENNEKING H., HOFFMEISTER B. 2010 JOURNAL OF CRANIO-MAXILLO-FACIAL SURGERY 39 (2011) 554-561. THIS REPORT IS FOR TWO UNKNOWN INTERNAL MIDFACE DISTRACTOR SYSTEMS. 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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE NECROTIZING SOFT TISSUE INFECTION OF THE SCALP AFTER FRONTO-FACIAL ADVANCEMENT BY INTERNAL DISTRACTION IN A (B)(6) YEAR OLD GIRL WITH GORLIN CHAUDHRY MOSS SYNDROME E A CASE REPORT ADOLPHS N., KLEIN M., HABERL E., GRAUL-NEUMANN L., MENNEKING H., HOFFMEISTER B. 2010 JOURNAL OF CRANIO-MAXILLO-FACIAL SURGERY 39 (2011) 554-561 A CASE REPORT REGARDING A (B)(6) YEAR OLD GIRL AFFECTED BY GORLIN CHAUDHRY MOSS SYNDROME, THAT REQUIRED CORRECTION OF HER COMPLEX CRANIOFACIAL MALFORMATION DUE TO FUNCTIONAL AND PSYCHOSOCIAL INDICATIONS. TWO SYNTHES IMD DEVICES (INTERNAL MIDFACE DISTRACTOR SYSTEM, SYNTHES (B)(4), (B)(6)) WERE MOUNTED BILATERALLY IN THE ZYGOMATICO-TEMPORAL REGIONS WITH THE DISTRACTION VECTOR CONVERGING IN AN ANTEROCAUDAL DIRECTION. POSTOPERATIVELY THE PATIENT SHOWED SIGNS OF NECROSIS. MULTIPLE DEBRIDEMENTS WERE REQUIRED OF THE ELEVATED FLAP AFTER NECROTIZING SOFT TISSUE INFECTION. SHE WAS ALSO TREATED WITH DOUBLE ANTIBIOTIC THERAPY. DEBRIDEMENT OF THE NECROTIC SKIN WAS PERFORMED ON THREE DIFFERENT OCCASIONS. ON THE THIRD DEBRIDEMENT OF NECROTIC SCALP TO ACHIEVE VITAL TISSUES LEADING TO PARTIAL EXPOSURE OF THE FRONTAL BONE AND PARIETAL DURA. FURTHER WOUND MANAGEMENT CONSISTED OF DAILY CHANGES OF ASEPTIC DRESSINGS AND CONDITIONING OF THE WOUND IN ORDER TO CLOSE THE DEFECT WITH SPLIT DERMAL MESH GRAFTS FROM THE THIGH. THE DEVICE WAS REMOVED ON A SCHEDULED DATE (B)(6) 2009. REMOVAL WAS PERFORMED WITHOUT PROBLEMS, NO RELEVANT LOOSENING OF THE FOOTPLATES WAS SEEN. 15 MONTHS FOLLOW-UP AFTER DEVICE REMOVAL WAS UNEVENTFUL WITH IMPROVED FUNCTION OF THE UPPER AIRWAY, IMPROVED PROFILE AND CLASS I OCCLUSAL RELATION. THIS IS REPORT 1 OF 1 FOR COM-(B)(4). THIS REPORT IS FOR A UNKNOWN 2 MIDFACE DISTRACTOR SYSTEM. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676623 MANDIBULAR DISTRACTION DEVICES MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention