BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7670646 · Received July 9, 2018

    Report

    Report Number
    8030965-2018-54884
    Event Type
    Injury
    Date Received
    July 9, 2018
    Date of Event
    March 12, 2018
    Report Date
    June 12, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN; (B)(6) 2018 IS THE DATE THE LITERATURE ARTICLE WAS PUBLISHED. 510K: THIS REPORT IS FOR AN UNKNOWN SYNTHES NARROW LIMITED CONTACT DYNAMIC COMPRESSION PLATE (LC DCP)/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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CHAN L. ET AL (2018) NON-PROSTHETIC PERI-IMPLANT FRACTURES: CLASSIFICATION, MANAGEMENT AND OUTCOMES. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY VOLUME 138, PAGES 791-802 (SINGAPORE). THE AIMS OF THIS RETROSPECTIVE STUDY WERE TO REVIEW PATTERNS OF INJURY, MANAGEMENT AND OUTCOMES AND TO ATTEMPT TO CLASSIFY NON-PROSTHETIC PERI-IMPLANT FRACTURE (NPPIFS) INTO A SYSTEM THAT MAY AID FURTHER RESEARCH AND STUDY. A NON-PROSTHETIC PERI-IMPLANT FRACTURE (NPPIF) IS DEFINED AS A FRACTURE IN A BONE WITH AN EXISTING NON-PROSTHETIC IMPLANT SUCH AS AN EXTRAMEDULLARY PLATE AND SCREWS OR AN INTRAMEDULLARY NAIL. A TOTAL OF 53 PATIENTS 31 MALES AND 22 FEMALES WITH A MEAN AGE OF 64 YEARS (60 TOTAL NPPIFS) WERE INCLUDED IN THIS STUDY. OF THE 53 PATIENTS, 27 PATIENTS WERE REVISED WITH UNKNOWN SYNTHES DEVICES. AVERAGE FOLLOW-UP WAS 16 MONTHS (RANGE 0¿75). THE FOLLOWING POST-OPERATIVE COMPLICATIONS WERE OBSERVED. A (B)(6) FEMALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES LIMITED CONTACT DYNAMIC COMPRESSION PLATE (LC DCP) OBTAINED NPPIF (RIGHT RADIUS AND ULNA AND LEFT RADIUS AND ULNA) FRACTURES DUE TO LOW ENERGY FALL. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES 3.5 LIMITED CONTACT DYNAMIC COMPRESSION PLATE (LC DCP). PATIENT EXPERIENCED REFRACTURE TWICE ON BOTH RADIUS AND ULNA OF THE LEFT AND RIGHT UPPER EXTREMITY WHICH REQUIRED REVISION. THIS REPORT IS FOR AN UNKNOWN SYNTHES NARROW LIMITED CONTACT DYNAMIC COMPRESSION PLATE (LC DCP). THIS REPORT IS 8 OF 9 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513699 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention