BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4707664 · Received April 20, 2015

    Report

    Report Number
    2520274-2015-13177
    Event Type
    Injury
    Date Received
    April 20, 2015
    Report Date
    April 6, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. "INTRAORAL EXTERNAL OBLIQUE RIDGE COMPARED WITH TRANSBUCCAL LATERAL CORTICAL PLATE FIXATION FOR THE TREATMENT OF FRACTURES OF THE MANDIBULAR ANGLE: PROSPECTIVE RANDOMISED TRIAL " LAVERICK ET AL. BRITISH JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY, 50 (2012) 344¿349. UNITED KINGDOM ARTICLE. THIS REPORT IS FOR AN UNKNOWN (CMF) INTERMAXILLARY FIXATION SCREWS / UNKNOWN QUANTITY / 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: " INTRAORAL EXTERNAL OBLIQUE RIDGE COMPARED WITH TRANSBUCCAL LATERAL CORTICAL PLATE FIXATION FOR THE TREATMENT OF FRACTURES OF THE MANDIBULAR ANGLE: PROSPECTIVE RANDOMISED TRIAL " LAVERICK ET AL. BRITISH JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY, 50 (2012) 344¿349. UNITED KINGDOM ARTICLE. THE AIM OF THIS STUDY WAS TO INVESTIGATE THE NULL HYPOTHESIS THAT THERE IS NO DIFFERENCE IN THE INCIDENCE OF POSTOPERATIVE REMOVAL OF AN INFECTED PLATE BETWEEN MINIPLATES PLACED ON THE MANDIBULAR EXTERNAL OBLIQUE RIDGE OR THOSE ON THE BUCCAL SURFACE OF THE MANDIBLE BY A TRANSBUCCAL APPROACH TO TREAT A FRACTURE OF THE ANGLE OF THE MANDIBLE. OF THE 320 PATIENTS WHO PROVIDED INFORMED CONSENT, 15 PATIENTS HAD BILATERAL ANGLE FRACTURES GIVING A TOTAL OF 335 ANGLE FRACTURES ENTERED INTO THE TRIAL. SEVENTY PATIENTS WERE LOST TO FOLLOW UP, AND SO A TOTAL OF 261 FRACTURES FOLLOWED UP FOR A MEAN POSTOPERATIVE PERIOD OF 6.7 WEEKS WERE ANALYSED. VARIOUS METHODS WERE USED TO REDUCE THE FRACTURE AND HOLD THE CORRECT OCCLUSION WHILE THE PLATE WAS POSITIONED. 15/261 (6 %) FRACTURES WERE REDUCED WITH ¿INTERMAXILLARY FIXATION (IMF) SCREWS¿ OR ¿RAPID IMF¿ (SYNTHES). FRACTURES THAT REQUIRED A FURTHER PERIOD OF FIXATION AFTER THE REMOVAL OF THE PLATES WERE OPERATED ON AT A MEAN TIME OF 3.5 WEEKS (RANGE 3 TO 4 WEEKS). THERE WAS A HIGHLY SIGNIFICANT DIFFERENCE BETWEEN THE RATE OF REMOVAL OF PLATES PLACED INTRAORALLY ON THE EXTERNAL OBLIQUE RIDGE AND PLATES PLACED TRANSBUCCALLY. THE TRANSBUCCAL PLATE (NON-SYNTHES) HAD A SIGNIFICANTLY LOWER POSTOPERATIVE INFECTION RATE (6/124, 5%) COMPARED WITH 28/137 (20%) OF RIDGE PLATES (NON-SYNTHES) (P = 0.001). THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE GROUPS IN THE INCIDENCE OF DAMAGE TO THE INFERIOR DENTAL AND FACIAL NERVES, OCCLUSION AFTER REDUCTION OF THE FRACTURE, OR METHOD OF REDUCTION. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN (CMF) INTERMAXILLARY FIXATION SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261007 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention