BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7894019 · Received September 20, 2018

    Report

    Report Number
    8030965-2018-56491
    Event Type
    Injury
    Date Received
    September 20, 2018
    Report Date
    August 28, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE 213 MALES AND 46 FEMALES WITH AN AVERAGE AGE OF 39 YEARS OLD (RANGE, 13-73 YEARS). 510K: THIS REPORT IS FOR AN UNKNOWN SYNTHES 3.5MM RECONSTRUCTION PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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 REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MEEUWIS MA, PULL TER GUNNE AF, VERHOFSTAD MHJ, VAN DER HEIJDEN FHWM (2017). CONSTRUCT FAILURE AFTER OPEN REDUCTION AND PLATE FIXATION OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES. INJURY, INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED. VOLUME 48. ISSUE 3. PAGES 715-719. ((B)(6)). THE PRIMARY AIM OF THIS RETROSPECTIVE STUDY WAS TO GIVE A DESCRIPTION OF CONSTRUCT FAILURE AFTER PLATE FIXATION OF MIDSHAFT CLAVICULAR FRACTURES. ITS SECONDARY AIM WAS TO IDENTIFY POSSIBLE RISK FACTORS FOR CONSTRUCT FAILURE INCLUDING PATIENT CHARACTERISTICS, FRACTURE TYPE, IMPLANT TYPE AND FRACTURE FIXATION METHOD. BETWEEN JANUARY 1, 2007 AND DECEMBER 31, 2015, A TOTAL OF 259 PATIENTS WITH FRESH MIDSHAFT CLAVICULAR FRACTURE TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION USING A 3.5-MM RECONSTRUCTION PLATE (LOCKING COMPRESSION DESIGN) OR A .3.5-MM PRESHAPED OR NONPRESHAPED SMALL FRAGMENT LOCKING COMPRESSION PLATE, WERE INCLUDED IN THE STUDY. THERE WERE 213 MALES AND 46 FEMALES WITH AN AVERAGE AGE OF 39 YEARS OLD (RANGE, 13-73 YEARS). FIFTY CLAVICULAR FRACTURES WERE FIXATED USING AN UNKNOWN SYNTHES 3.5MM RECONSTRUCTION PLATE AND 209 FRACTURES WITH AN UNKNOWN SYNTHES 3.5MM SMALL FRAGMENT LOCKING COMPRESSION PLATE. PATIENTS WERE FOLLOWED UP AT LEAST 2 WEEKS, 6 WEEKS (WITH RADIOGRAPHIC CONTROL) AND 3 MONTHS (WITH RADIOGRAPHIC CONTROL) AFTER SURGERY AND CONTINUED UNTIL THE FRACTURE WAS COMPLETELY CONSOLIDATED. COMPLICATIONS WERE REPORTED AS FOLLOWS: FIVE PATIENTS WHO HAD REVISION DUE TO BROKEN PLATES. THIS REPORT IS FOR AN UNKNOWN SYNTHES 3.5MM RECONSTRUCTION PLATE. THIS IS REPORT 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736583 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention