BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PHILOS PLATE/SCREWS

    MDR report key: 13497802 · Received February 9, 2022

    Report

    Report Number
    8030965-2022-00761
    Event Type
    Injury
    Date Received
    February 9, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNKNOWN PHILOS CONSTRUCT/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. 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. 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LEIBLEIN M., ET AL (2019) NONUNIONS OF THE HUMERUS TREATMENT CONCEPTS AND RESULTS OF THE LAST FIVE YEARS, CHINESE JOURNAL OF TRAUMATOLOGY VOLUME 22, PAGES 187-195 (GERMANY). THIS RETROSPECTIVE STUDY AIMS TO DESCRIBE THE TREATMENT CONCEPTS AND ENTITY AND PRESENT THE RESULTS OF PATIENTS TREATED FOR NONUNION OF THE HUMERUS IN OUR LEVEL ONE TRAUMA CENTER WITHIN THE LAST FIVE YEARS. BETWEEN JANUARY 2013 AND DECEMBER 2017, TWENTY-SIX PATIENTS (14 FEMALES AND 12 MALES) WITH MEDIAN AGE OF 59 YEARS (MEDIAN ¼ 59, MAD ¼ 15.26) WHO WERE TREATED FOR NONUNION OF THE HUMERUS (PROXIMAL, SHAFT, DISTAL) WERE INCLUDED IN THE STUDY. INITIAL TREATMENT OF THE FRACTURE INCLUDED THE USE A PHILOS PLATE. DURING REVISION, (REAMER/IRRIGATOR/ ASPIRATOR (RIA), EPOCA AND BETA-TRICALCIUM PHOSPHATE (CHRONOS®, SYNTHES GMBH, EIMATTSTR., (B)(6)) WERE USED. THE FOLLOWING COMPLICATIONS WERE REPORTED: A (B)(6) FEMALE PATIENT WITH MULTIFRAGMENTARY SHAFT-FRACTURE (AO TYPE 12C3) AND OPEN REDUCTION AND FIXATION WITH PHILOS. AFTER 12 WEEKS NO SIGNS OF CONSOLIDATION. AFTER 18 WEEKS AND 4 WEEKS OF LOW-INTENSITY PULSED ULTRASOUND (LIPUS) DISTINCTLY PROGREDIENT CONSOLIDATION AND BONEY BRIDGING. THIS REPORT IS FOR AN UNKNOWN SYNTHES PHILOS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683931 UNK - CONSTRUCTS: PHILOS PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention