BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 10483075 · Received September 2, 2020

    Report

    Report Number
    8030965-2020-06561
    Event Type
    Injury
    Date Received
    September 2, 2020
    Report Date
    August 18, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: PLATE/SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BOUDISSA, M. ET AL (2020), TECHNICAL NOTE: POSTERIOR TRANSILIAC PLATING IN VERTICALLY UNSTABLE SACRAL FRACTURE, ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, VOL. 106 (1), PAGES 85-88 (FRANCE). THE AIM OF THIS STUDY OF TECHNICAL NOTE IS TO DESCRIBE THE POSTERIOR TRANSILIAC PLATING METHOD, ITS PROS AND CONS AND COMPLICATIONS. CLINICAL AND RADIOLOGICAL RESULTS ARE REPORTED FOR A SERIES OF 10 VERTICALLY UNSTABLE PELVIC FRACTURES. BETWEEN JANUARY 2007 TO DECEMBER 2017, A TOTAL OF 10 PATIENTS (5 MALE AND 5 FEMALE) WITH A MEAN AGE OF 43.9±20.2 YEARS WERE INCLUDED IN THE STUDY. SURGERY WAS PERFORMED USING A 4.5 LOCKING COMPRESSION PLATE (JOHNSON & JOHNSON MEDICAL, SWITZERLAND). PATIENTS WERE FOLLOWED UP CLINICALLY AND RADIOLOGICALLY AT 45 DAYS, 3 MONTHS, 6 MONTHS, AND 1 YEAR. THE MEAN FOLLOW-UP PERIOD WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: THERE WERE 7 COMPLICATIONS: 4 CASES OF HARDWARE REMOVAL FOR DISCOMFORT, AND 3 OF SEPSIS REQUIRING SURGICAL LAVAGE. THE MAJEED SCORE WAS MODERATE IN 1 PATIENT AND POOR IN 1 PATIENT. HANNOVER SCORE WAS MODERATE IN 2 PATIENTS. THIS REPORT IS FOR AN UNKNOWN SYNTHES PLATES AND UNKNOWN SYNTHES SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947114 UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention