BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7331402 · Received March 12, 2018

    Report

    Report Number
    8030965-2018-51952
    Event Type
    Injury
    Date Received
    March 12, 2018
    Report Date
    February 12, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ARMAR B. S., KALPESH M. G., PATEL A. M., TANDEL R. C., SHAH J. (2016). USE OF A SINGLE 2.0-MM LOCKING AO RECONSTRUCTION TITANIUM PLATE IN LINEAR, NON-COMMINUTED, MANDIBLE FRACTURES. ANALS OF MAXILLOFACIAL SURGERY. 4:1, PP. 51-54. INDIA. 510K: THIS REPORT IS FOR AN UNKNOWN SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. PATIENT CODE IS FOR PARESTHESIA IN THE DISTRIBUTION OF MENTAL NERVE, AND AN ASSOCIATED SUBCONDYLAR FRACTURE REQUIRED POSTOPERATIVE INTERMAXILLARY LIGATION 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE PARMAR B. S., KALPESH M. G., PATEL A. M., TANDEL R. C., SHAH J. (2016). USE OF A SINGLE 2.0-MM LOCKING AO RECONSTRUCTION TITANIUM PLATE IN LINEAR, NON-COMMINUTED, MANDIBLE FRACTURES. ANALS OF MAXILLOFACIAL SURGERY. 4:1, PP. 51-54. INDIA. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE USE OF A SINGLE 2.0-MM LOCKING RECONSTRUCTION TITANIUM PLATE (AO) IN LINEAR, NON-COMMINUTED, MANDIBLE FRACTURES. THE STUDY INCLUDED 10 PATIENTS WITH LINEAR MANDIBULAR FRACTURES. EACH OF THE PATIENTS WERE IMPLANTED WITH A SINGLE AO 2.0 MM 6 HOLE LOCKING RECONSTRUCTION PLATE AND 6, 2.0 MM, 10 MM LOCKING SCREWS (SYNTHES-MAXILLOFACIAL (B)(4)) AS TREATMENT. ONE PATIENT REPORTED A COMPLICATION OF PARESTHESIA IN THE DISTRIBUTION OF MENTAL NERVE, WHICH WAS SUCCESSFULLY MANAGED CONSERVATIVELY WITH MEDICATION. ANOTHER PATIENT WITH AN ASSOCIATED SUBCONDYLAR FRACTURE REQUIRED POSTOPERATIVE INTERMAXILLARY LIGATION WITH TRACTION ELASTICS FOR 3 WEEKS POSTOPERATIVELY. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW, UNKNOWN QUANTITY A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174098 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention