BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7307543 · Received March 1, 2018

    Report

    Report Number
    8030965-2018-51605
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    November 3, 2008
    Report Date
    February 20, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (510K): THIS REPORT IS FOR UNKNOWN 6MM SCREWS (QUANTITY UNKNOWN). PART AND LOT NUMBERS ARE UNKNOWN. WITHOUT THE SPECIFIC PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: A.W. SUGAR ET AL. (2009). A RANDOMISED CONTROLLED TRIAL COMPARING FIXATION OF MANDIBULAR ANGLE FRACTURES WITH A SINGLE MINIPLATE PLACED EITHER TRANSBUCALLY AND INTRA-ORALLY, OR INTRA-ORALLY ALONE. "INTERNATIONAL ASSOCIATION OF ORAL AND MAXILLOFACIAL SURGEONS: 2009; 38: 241-245. UNITED KINGDOM. THE AIM OF THIS STUDY WAS TO COMPARE OUTCOMES FOLLOWING FIXATION OF MANDIBULAR ANGLE FRACTURES WITH A COMBINED TRANSBUCCAL AND INTRA-ORAL TECHNIQUE IN WHICH A SINGLE MINIPLATE IS FIXED TO THE LATERAL ASPECT OF THE MANDIBLE, WITH THE STANDARD INTRA-ORAL TECHNIQUE IN WHICH A SINGLE MINIPLATE IS FIXED TO THE ANTERIOR ASPECT OF THE MANDIBULAR EXTERNAL OBLIQUE RIDGE. A 140 CONSECUTIVE PATIENTS WERE RANDOMLY ALLOCATED TO THE TWO TREATMENT GROUPS. COMPLICATIONS WERE NOTED AND COMPARED. THE COMBINED TRANSBUCCAL/INTRA-ORAL PROCEDURE WAS SAFER AND MORE EFFECTIVE THAN THE STANDARD INTRA-ORAL TECHNIQUE IN TERMS OF COMPLICATIONS REQUIRING FURTHER SURGERY. FIXATION WAS WITH A 4 HOLE CENTRALLY SPACED MANDIBULAR MINIPLATE (SYNTHES FOR 2.0MM SCREWS). A MINI-AIR DRILL WAS USED WITH COPIOUS SALINE IRRIGATION FOR COOLING AND ALL SCREWS PLACED WERE 6MM LONG. THE FOLLOWING COMPLICATIONS WERE REPORTED: IN 5 CASES, THE MINIPLATE WAS REMOVED BECAUSE THE FRACTURE HAD NOT UNITED AND A RECONSTRUCTION PLATE HAD TO BE INSERTED. CODED REASON FOR PLATE REMOVAL WAS LOOSE/LOST SCREWS, INFECTION AND NON-UNION OF FRACTURE. OVERALL, THERE WAS A PRESENCE OF BREAKDOWN AND/OR GRANULATION AT INCISION SITES. PRESENCE OF INFECTION WITH SINUS AND PUS. PRESENCE OF EXPOSED PLATES. PRESENCE OF A DRY SOCKETS. PRESENCE OF MALOCCLUSION. MEASUREMENT OF INTER-INCISAL MOUTH OPENING. THIS REPORT IS FOR UNKNOWN 6MM SCREWS (QUANTITY UNKNOWN) WHICH WERE IMPLANTED IN 5 PATIENTS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4). A COPY OF THE LITERATURE ARTICLE (OR ABSTRACT) WILL BE SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150533 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention