BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7362451 · Received March 22, 2018

    Report

    Report Number
    8030965-2018-52312
    Event Type
    Injury
    Date Received
    March 22, 2018
    Date of Event
    March 12, 2010
    Report Date
    February 22, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S IDENTIFIER AND WEIGHT ARE UNKNOWN. G5-510K: THIS REPORT IS FOR AN UNKNOWN 2.4-MM LOCKING RECONSTRUCTION PLATE. PART AND LOT NUMBERS ARE UNKNOWN. WITHOUT THE SPECIFIC PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. COMPLAINANT PART 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: HERFORD, ALAN S. AND CICCIU, MARCO (2010) RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN TYPE 2 JAW RECONSTRUCTION IN PATIENTS AFFECTED BY GIANT CELL TUMOR. THE JOURNAL OF CRANIOFACIAL SURGERY VOLUME 21, PAGES 1970 - 1975. (ITALY). THIS STUDY AIMS TO UNDERLINE THE EFFECT OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN TYPE 2 (RHBMP-2) IN A COLLAGEN CARRIER WITH CONCOMITANT BONE GRAFTING MATERIAL IN THE RESTORATION OF CONTINUITY CRITICAL-SIZE DEFECTS AFTER GCT RESECTION IN THE MANDIBLE. THE STUDY INVOLVED A (B)(6) AT FOUR (4) MONTHS GESTATION WHO WAS DIAGNOSED WITH GIANT CELL TUMOR (GCT). TO TREAT THE TUMOR, THE PATIENT UNDERWENT A MAXILLOMANDIBULAR FIXATION, USING AN INFERIOR 2.4-MM LOCKING RECONSTRUCTION PLATE AND A SUPERIOR RECONSTRUCTIVE PLATE WAS PLACED TO MAINTAIN THE HEIGHT OF THE DEFECT. COMPLICATIONS OCCURRED SEVEN (7) MONTHS AFTER THE FIRST SURGERY: THE CLINICAL EXAMINATION SHOWED A PARTIAL EXPOSURE OF THE SUPERIOR PLATE. THIS REPORT IS FOR AN UNKNOWN 2.4-MM LOCKING RECONSTRUCTION PLATE. A COPY OF THE LITERATURE ABSTRACT IS ATTACHED TO THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204657 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention