BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 10608302 · Received September 30, 2020

    Report

    Report Number
    8030965-2020-07564
    Event Type
    Injury
    Date Received
    September 30, 2020
    Report Date
    September 16, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CAMPANA, V. ET AL (2019), TREATMENT OF DISTAL FEMUR FRACTURES WITH VA-LCP CONDYLAR PLATE: A SINGLE TRAUMA CENTRE EXPERIENCE, INJURY, VOL. XX (XX), PAGES 1-6, HTTPS://WWW.INJURYJOURNAL.COM/ARTICLE/S0020-1383(19)30684-9/ABSTRACT (ITALY). THE AIM OF THIS RETROSPECTIVE STUDY IS TO EVALUATE FUNCTIONAL OUTCOME, FRACTURE HEALING, AND THE COMPLICATIONS OF DISTAL FEMORAL FRACTURES USING SYNTHES VA-LCP CURVED CONDYLAR PLATES. BETWEEN OCTOBER 2017 TO SEPTEMBER 2018, A TOTAL OF 42 PATIENTS (14 MALE AND 28 FEMALE) WITH A MEAN AGE OF 65 YEATS (RANGE 19 TO 101 YEARS) WERE TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION. SURGERY WAS PERFORMED USING A SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR PLATE. FOLLOW-UP WERE PERFORMED AT 4 WEEKS, 3 MONTHS, 6 MONTHS AND 1 YEAR. THE MEAN FOLLOW-UP WAS 8 MONTHS (RANGE 3¿17 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 2 PATIENTS DIED IN THE FIRST 12 MONTHS AFTER SURGERY. 3 PATIENTS HAD AN ALIGNMENT VARIATION GREATER THAN 5° IN VARUS-VALGUS OR IN FLEXION-EXTENSION WHEREAS 2 PATIENTS SHOWED AN ALTERED EXTERNAL ROTATION OF 10 °UP TO 15 °COMPARED TO THE CONTRALATERAL SIDE. DURING THE FOLLOW UP, 3 PATIENTS HAD AN EARLY POSTOPERATIVE COMPLICATION: SUPERFICIAL INFECTION IN 2 AND FAILURE OF REDUCTION IN 1, AND 4 CASES HAD A LATE COMPLICATION: LATE INFECTION IN 1 PATIENT, IMPLANT FAILURE IN 2, AND NONUNION IN 1. 5 CASES REQUIRED ADDITIONAL SURGICAL PROCEDURES. (TABLE 2). 3 CASES DID NOT HEAL (7%): ONE DUE TO A FAILURE OF THE DEVICE AND THE OTHERS DUE TO PSEUDARTHROSIS. THIS REPORT IS FOR AN UNKNOWN SYNTHES PLATE/SCREWS CONSTRUCTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069741 UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION ,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention