BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION BONE

    MDR report key: 4493991 · Received February 9, 2015

    Report

    Report Number
    2520274-2015-10806
    Event Type
    Injury
    Date Received
    February 9, 2015
    Report Date
    February 2, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. RECONSTRUCTION PLATES USED IN THE SURGERY FOR MANDIBULAR DISCONTINUITY DEFECT GUK-JIN S., EUN-GYU J., JONG-SUNG L., SO-YOUNG C., JIN-WOOK K., TAE-GEON K., JUN-YOUNG P.J KOREAN ASSOC ORAL MAXILLOFAC SURG 2014;40:266-271. THIS REPORT IS FOR UNKNOWN PLATE, UNKNOWN PART/UNKNOWN LOT. 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

    LITERATURE ABSTRACT: RECONSTRUCTION PLATES USED IN THE SURGERY FOR MANDIBULAR DISCONTINUITY DEFECT GUK-JIN S., EUN-GYU J., JONG-SUNG L., SO-YOUNG C., JIN-WOOK K., TAE-GEON K., JUN-YOUNG P.J KOREAN ASSOC ORAL MAXILLOFAC SURG 2014;40:266-271. THE PURPOSE OF THIS STUDY WAS TO ANALYZE THE SURVIVAL RATE OF RECONSTRUCTION PLATES THAT WERE USED TO CORRECT MANDIBULAR DISCONTINUITY DEFECTS. WE ANALYZED CLINICAL AND RADIOLOGICAL DATA OF 36 PATIENTS (20 MALE AND 16 FEMALE MEAN AGE 45.7 YEARS). THE CLINICAL HISTORY, RADIOLOGICAL DATA, AND SURVIVAL RATE OF THE RECONSTRUCTION PLATES WERE ANALYZED ACCORDING TO AGE, GENDER, LOCATION OF DEFECT, REMOVAL OF THE CORONOID PROCESS, USE OF BONE GRAFT IN THE RECONSTRUCTION, AND WHETHER POSTOPERATIVE RADIATION THERAPY (RT) WAS PERFORMED. SYNTHES RECONSTRUCTION PLATES (SYNTHES, (B)(4)) OR COMPETITORS RECONSTRUCTION PLATES. TWENTY-SEVEN SYNTHES RECONSTRUCTION PLATES AND 9 WERE THE COMPETITORS PLATES . PLATE-RELATED COMPLICATIONS DEVELOPED IN 8 PATIENTS, 7 OF WHICH UNDERWENT PLATE REMOVAL. NO SIGNIFICANT DIFFERENCES WERE FOUND IN PLATE SURVIVAL RATE ACCORDING TO AGE, GENDER, LOCATION OF DEFECT, DEFECT SIZE, OR WHETHER A BONE GRAFT PROCEDURE WAS PERFORMED. HOWEVER, THERE WERE DIFFERENCES IN THE PLATE SURVIVAL RATE THAT DEPENDED ON WHETHER THE PATIENT UNDERWENT CORONOIDECTOMY OR POSTOPERATIVE RT. IN THE EARLY STAGES PLATE FRACTURE WAS THE MOST COMMON COMPLICATION, BUT IN THE LATER STAGES SCREW LOOSENING WAS THE MOST COMMON COMPLICATION. THE FOLLOWING ARE THE PATIENTS THAT HAD COMPLICATIONS WITH SYNTHES. A (B)(6) MALE HAD LOOSENING OF SCREWS THAT REQUIRE REMOVAL. CONCLUSION: IT IS IMPORTANT TO ESTABLISH THE TIME-RELATED RISK OF COMPLICATIONS SUCH AS PLATE FRACTURE OR SCREW LOOSENING. CORONOIDECTOMY SHOULD BE CONSIDERED IN MOST CASES TO PREVENT COMPLICATIONS. POSTOPERATIVE RT CAN AFFECT THE SURVIVAL RATE AND HAZARD RATE AFTER A RECONSTRUCTION PLATE IS FITTED. THIS REPORT IS FOR A ONE UNKNOWN PLATE. A COPY OF THE LITERATURE ABSTRACT IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS 1 OF 7 REPORTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93157 PLATE, FIXATION BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention