BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANDIBLE DISTRACTION DEVICES

    MDR report key: 5381176 · Received January 20, 2016

    Report

    Report Number
    2520274-2016-10339
    Event Type
    Injury
    Date Received
    January 20, 2016
    Date of Event
    January 25, 2009
    Report Date
    January 11, 2016
    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

    BILATERAL COMPLEX ODONTOMAS: A RARE COMPLICATION OF EXTERNAL MANDIBULAR DISTRACTION IN THE NEONATE (2009) HAMMOUDEH, J.A., KLEIBER, G.M., NAZARIAN-MOBIN, S. S., AND URATA, M. M.JOURNAL OF ORTHOPAEDICS, THE JOURNAL OF CRANIOFACIAL SURGERY 20:3: 973-975. UNITED STATES. THIS REPORT IS FOR AN UNKNOWN CMF, MULTI-VECTOR DISTRACTOR /UNKNOWN QUANTITY/UNKNOWN LOT. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(6). (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. HAMMOUDEH, J.A., KLEIBER, G.M., NAZARIAN-MOBIN, S. S., AND URATA, M. M. (2009) "BILATERAL COMPLEX ODONTOMAS: A RARE COMPLICATION OF EXTERNAL MANDIBULAR DISTRACTION IN THE NEONATE". THE JOURNAL OF CRANIOFACIAL SURGERY 20:3: 973-975. UNITED STATES. THIS STUDY PRESENTS AN UNUSUAL COMPLICATION OF EXTERNAL MANDIBULAR DISTRACTION IN A CHILD WITH BILATERAL COMPLEX ODONTOMAS IN THE POSTERIOR MANDIBLE. THE PATIENT IS A (B)(6) GIRL WITH A HISTORY OF MICROGNATHIA, GLOSSOPTOSIS, AND RESPIRATORY DISTRESS (PIERRE-ROBIN SEQUENCE) TREATED WITH NEONATAL EXTERNAL MANDIBULAR DISTRACTION. SHE WAS REFERRED WITH BILATERAL AMORPHIC RADIO-OPAQUE MASSES IN THE BODY OF THE MANDIBLE. THIS PATIENT WAS BORN AT (B)(6) GESTATION WITH A COMPLETE CLEFT OF THE HARD AND SOFT PALATES (SECONDARY PALATE). SHE DEVELOPED RESPIRATORY DISTRESS AND WAS DIAGNOSED WITH PIERRE ROBIN SEQUENCE. HER MANDIBLE WAS SEVERELY RETROGNATHIC. MANDIBULAR DISTRACTION WAS PERFORMED AT THREE WEEKS OF AGE USING AN EXTERNAL SYNTHES MULTI-VECTOR DISTRACTOR (SYNTHES, (B)(4)). STANDARD DISTRACTION PROTOCOL INCORPORATING THE LATENCY, DISTRACTION, AND CONSOLIDATION PHASES FOLLOWED. THE HARDWARE WAS REMOVED UNEVENTFULLY AFTER APPROPRIATE CONSOLIDATION, AND THE PATIENT DID WELL POSTOPERATIVELY. AT (B)(6), PERIAPICAL DENTAL RADIOGRAPHS DEMONSTRATED BILATERAL AMORPHIC RADIO-OPAQUE MASSES IN THE POSTERIOR SEGMENTS OF THE MANDIBLE. THE MASSES WERE ENUCLEATED WITHOUT COMPLICATION. THE TUMORS WERE DECALCIFIED AND STAINED, AND THE DIAGNOSIS WAS CONFIRMED. HISTOPATHOLOGIC EXAMINATION OF THE MASSES WAS CONSISTENT WITH COMPLEX ODONTOMAS BILATERALLY. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN MANDIBULAR DISTRACTOR. A COPY OF THIS LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39358 MANDIBLE DISTRACTION DEVICES MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention