BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PLATE

    MDR report key: 4476033 · Received February 2, 2015

    Report

    Report Number
    2520274-2015-10699
    Event Type
    Injury
    Date Received
    February 2, 2015
    Date of Event
    August 25, 2011
    Report Date
    January 21, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. TAN, S.K., LO, J., & ZWAHLEN, R.A. (2011). "ARE POSTOPERATIVE INTRAVENOUS ANTIBIOTICS NECESSARY AFTER BIMAXILLARY ORTHOGNATHIC SURGERY? A PROSPECTIVE, RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL." INTERNATIONAL JOURNAL OF ORAL & MAXILLOFACIAL SURGERY. (40: 1363-1368). THIS REPORT IS FOR AN UNKNOWN COMPACT MF 2.0 PLATING SYSTEM UNKNOWN QUANTITY/UNKNOWN LOT. 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, TAN, S.K., LO, J., & ZWAHLEN, R.A. (2011). "ARE POSTOPERATIVE INTRAVENOUS ANTIBIOTICS NECESSARY AFTER BIMAXILLARY ORTHOGNATHIC SURGERY? A PROSPECTIVE, RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL." INTERNATIONAL JOURNAL OF ORAL & MAXILLOFACIAL SURGERY. (40: 1363-1368). A STUDY WAS DONE AT A (B)(6) INVESTIGATING WHETHER A POSTOPERATIVE ORAL ANTIBIOTIC REGIMEN IS AS EFFECTIVE AS A INTRAVENOUS ANTIBIOTICS AFTER BIMAXILLARY ORTHOGNATHIC SURGERY USING AN UNKNOWN COMPACT MF 2.0 PLATING SYSTEM. FORTY-TWO PATIENTS UNDERWENT BIMAXILLARY ORTHOGNATHIC SURGERY BETWEEN DECEMBER 2008 AND MAY 2010. GROUP 1 WHICH INCLUDED 13 FEMALE AND 8 MALE PATIENTS WITH A MEAN AGE OF 26.3 YEARS RECEIVED ORAL AMOXICILLIN 500 MG THREE TIMES A DAY AND GROUP 2 WHICH INCLUDED 15 FEMALE AND 6 MALE PATIENTS WITH A MEAN AGE OF 25.7 YEARS RECEIVED INTRAVENOUS AMPICILLIN 1 G FOUR TIME A DAY. BOTH GROUPS TOOK ORAL AMOXICILLIN FOR THREE MORE DAYS. OF THE 42 PATIENTS, 9 PATIENTS DEVELOPED AN INFECTION, 3 PATIENTS FROM GROUP 1 AND 6 FROM GROUP 2. A (B)(6) MALE UNDERWENT A MAXILLA SURGERY WITH SEGMENTALIZATION, RAMUS SURGERY, ANTERIOR MANDIBULAR SURGERY AND GENIOPLASTY DEVELOPED INFECTION IN THE RIGHT ANTERIOR MANDIBLE 5 DAYS POSTOPERATIVELY USING INTERVENOUS AND ORAL ANTIBIOTICS. THIS IS REPORT 3 OF 9 FOR (B)(4). THIS REPORT FOR AN UNKNOWN COMPACT MF 2.0 PLATING SYSTEM. NO REPORTED PRODUCT PROBLEM. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74549 BONE PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention