BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES

    MDR report key: 9612957 · Received January 21, 2020

    Report

    Report Number
    8030965-2020-00522
    Event Type
    Injury
    Date Received
    January 21, 2020
    Report Date
    December 27, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN PLATE/ UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN JANUARY 2011 TO JUNE 2016. 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. (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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YU, Q. ET AL. (2019), SURGICAL TREATMENT OF AVULSION FRACTURE AROUND JOINTS OF EXTREMITIES USING HOOK PLATE FIXATION, BMC MUSCULOSKELETAL DISORDERS, VOL. 20, NUMBER, 200, PAGES 1-7 (CHINA), HTTPS://DOI.ORG/10.1186/S12891-019-2585-1. THE PURPOSE OF THE PRESENT STUDY WAS TO SUMMARIZE CLINICAL DATA OF PATIENTS WITH AVULSION FRACTURES AROUND JOINTS OF THE EXTREMITIES TREATED WITH HOOK PLATE FIXATION. MORE IMPORTANTLY, IT WAS OUR GOAL TO ASSESS THE NECESSITY OF SURGERY, THE FLAW OF THE MAINSTREAM INTERNAL FIXATION AS WELL AS THE SPECIFIC CHARACTERISTICS AND THERAPEUTIC OUTCOMES OF HOOK PLATE. FROM JANUARY 2011 TO JUNE 2016, A TOTAL OF 60 PATIENTS (35 MALES AND 25 FEMALES) WITH A MEAN AGE OF 43.7 (RANGE 20 TO 73 YEARS) WERE TREATED WITH INTERNAL FIXATION USING AN AO HOOK PLATE. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: IN THE LAST FOLLOW-UP, 3 PATIENTS WITH AVULSION FRACTURES OF THE HUMERAL GREATER TUBEROSITY HAD SHOULDER JOINT ADHESION AND PERI HUMERAL INFLAMMATION, AND THE FUNCTIONAL RECOVERY OF SHOULDER JOINT WAS POOR. 5 PATIENTS HAD MILD JOINT FIBROSIS. 35 PATIENTS HAD THEIR INTERNAL FIXATION REMOVED AFTER 1 YEAR OF SURGERY. THIS REPORT IS FOR AN AO HOOK PLATE. THIS REPORT IS FOR ONE UNKNOWN PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75916 UNK - PLATES PLATE, FIXATION ,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention