BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 3961543 · Received July 28, 2014

    Report

    Report Number
    2520274-2014-12761
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    August 6, 2011
    Report Date
    June 30, 2013
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HUGENTOBLER, M, LENOIR V, AND SCOLOZZI P. THE JOURNAL OF CRANIOFACIAL SURGERY & VOLUME 22, NUMBER 6, NOVEMBER 2011. MANDIBULAR SAGITTAL SPLIT OSTEOTOMY: IS A BICORTICAL 2-SCREW OSTEOSYNTHESIS ADEQUATE? THREE UNKNOWN BICORTICAL SCREWS. 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 JOURNAL ARTICLE. HUGENTOBLER, M, LENOIR V, AND SCOLOZZI P. THE JOURNAL OF CRANIOFACIAL SURGERY & VOLUME 22, NUMBER 6, NOVEMBER 2011. MANDIBULAR SAGITTAL SPLIT OSTEOTOMY: IS A BICORTICAL 2-SCREW OSTEOSYNTHESIS ADEQUATE? IN THIS ARTICLE THE TRIAL PROSPECTIVELY EVALUATE THE ACCURACY AND RELIABILITY OF THE USE OF THE HUNSUCK/EPKERYTYPE MANDIBULAR SPLIT OSTEOTOMY TOGETHER WITH OSTEOSYNTHESIS WITH PLACEMENT OF 2 BICORTICAL POSITIONING SCREWS WITHOUT THE ADJUNCTIVE USE OF A POSTOPERATIVE MAXILLA-MANDIBULAR FIXATION IN THE TREATMENT OF MANDIBULAR DENTOFACIAL DEFORMITIES. IT ANALYZED THE CLINICAL AND RADIOLOGIC DATA OF 54 PATIENTS WITH DENTOFACIAL DEFORMITIES. FIFTY-ONE PATIENTS (94.5PERCENT) HAD A SUCCESSFUL TREATMENT OUTCOME WITHOUT COMPLICATIONS, 13 PATIENTS (24 PERCENT) DEVELOPED MINOR COMPLICATIONS, AND THREE PATIENTS (5.5 PERCENT) SUSTAINED A HARDWARE LOOSENING, 48 HOURS, 8 DAYS, AND 30 DAYS POSTOPERATIVELY, RESPECTIVELY, REQUIRING REMOVAL OF THE SCREWS AND REOSTEOSYNTHESIS WITH A 2.4-MM RECONSTRUCTION PLATE. NONE OF THE PATIENTS EXPERIENCED INFECTION OR NONUNION. THIS COMPLAINT IS FOR 3 UNKNOWN BICORTICAL SCREWS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437627 SCREW HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention