BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANDIBLE DISTRACTION DEVICES

    MDR report key: 4863474 · Received June 23, 2015

    Report

    Report Number
    2520274-2015-14530
    Event Type
    Injury
    Date Received
    June 23, 2015
    Report Date
    June 9, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN MAXILLARY 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. (B)(4).

    Description of Event or Problem · 1

    CLEFT MAXILLARY DISTRACTION VERSUS ORTHOGNATHIC SURGERY: CLINICAL MORBIDITIES AND SURGICAL RELAPSE. (2006). CHEUNG, L.K., CHUA, H. D., AND HAGG, M. B. PLASTIC RECONSTRUCTION SURGERY 118: 996. THIS WAS A RANDOMIZED CONTROLLED STUDY AIMED IN COMPARING THE POSTOPERATIVE CLINICAL MORBIDITIES IN CLEFT LIP AND PALATE IN PATIENTS TREATED WITH DISTRACTION OSTEOGENESIS VERSUS CONVENTIONAL ORTHOGNATHIC SURGERY. PATIENTS WERE AGED 16 YEARS OR OLDER. THE OPERATIONS WERE PERFORMED BETWEEN JUNE OF 2002 AND JULY OF 2004. TWENTY-NINE CLEFT LIP AND PALATE PATIENTS WITH MODERATE MAXILLARY HYPOPLASIA REQUIRING A MAXILLARY LE FORT I ADVANCEMENT OF 4 TO 10 MM WERE RANDOMIZED INTO TWO GROUPS FOR EITHER INTERNAL MAXILLARY DISTRACTORS OR IMMEDIATE FRAGMENT TRANSPOSITION USING MINIPLATES AND SCREW FIXATION. IN THE DISTRACTOR GROUP, FIXATION OF THE ZYGOMA AND THE MOLAR ALVEOLUS WAS ACHIEVED WITH AN INTRA-ORAL BONE-BORNE MAXILLARY DISTRACTOR (SYNTHES, WEST CHESTER, PA). ONE FEMALE PATIENT DEVELOPED A MUCOSAL INFECTION AROUND THE DISTRACTORS WHICH WERE CONTROLLED WITH INTRAVENOUS ANTIBIOTICS ADMINISTERED FOR A WEEK. THE COUNTRY OF ORIGIN IS (B)(6). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN MAXILLARY DISTRACTOR. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405457 MANDIBLE DISTRACTION DEVICES MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R