BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, BONE

    MDR report key: 5226999 · Received November 16, 2015

    Report

    Report Number
    2520274-2015-17295
    Event Type
    Injury
    Date Received
    November 16, 2015
    Date of Event
    September 15, 2006
    Report Date
    October 28, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. THE REPORT IS FRO AN UNKNOWN DISTRACTOR/UNKNOWN QUANTITY/UNKNOWN LOT. UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 JOURNAL ARTICLE, "CLEFT MAXILLARY DISTRACTION VERSUS ORTHOGNATHIC SURGERY: CLINICAL MORBIDITIES AND SURGICAL RELAPSE" CHEUNG, L.K., CHUA, H.D.P. HAGG, M.B. (2006). AMERICAN SOCIETY OF PLASTIC SURGEONS 118:996-1008. STUDY CONDUCTED IN CHINA. THE AUTHORS SUMMARIZED THE SURGICAL EXPERIENCE AND CLINICAL RESULTS OF 29 CLEFT 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. RESULTS INCLUDED: IN THE DISTRACTION GROUP (SYNTHES DEVICE), TWO OF THE 15 PATIENTS DEVELOPED INFECTION AROUND THE DISTRACTORS AND ONE PATIENT HAD AN OCCLUSAL RELAPSE. ONE FEMALE PATIENT DEVELOPED EARLY CLINICAL RELAPSE OF DENTAL OCCLUSION TO CLASS III MALOCCLUSION 2 MONTHS AFTER DISTRACTION SURGERY. THIS MALOCCLUSION WAS CORRECTED BY REPEATING THE LE FORT I OSTEOTOMY WHICH RELAPSED AGAIN AFTER 8 WEEKS OF THE SECOND OPERATION. THIS IS REPORT 3 OF 3 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN DISTRACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755564 PLATE, BONE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention