BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MATTA PLATE

    MDR report key: 15188305 · Received August 8, 2022

    Report

    Report Number
    0008031020-2022-00382
    Event Type
    Injury
    Date Received
    August 8, 2022
    Date of Event
    March 31, 2016
    Report Date
    August 8, 2022
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT OF HARDWARE REMOVAL COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, RADIOGRAPHS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY. DEVICE DISPOSITION UNKNOWN.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT OF ORTHOPEDIC SURGERY, CHONBUK NATIONAL UNIVERSITY HOSPITAL, KOREA¿. THE TITLE OF THIS REPORT IS ¿CLINICAL OUTCOME OF A PRECONTOURED SYMPHYSIS PUBIS PLATE WITH TENSION BAND WIRING FOR TRAUMATIC SYMPHYSIS PUBIS RUPTURE IN PELVIC FRACTURES, PUBLISHED ON MARCH 31, 2016, AND CAN BE FOUND AT HTTP://DX.DOI.ORG/10.20408/JTI.2016.29.1.22. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿PRO SYSTEM¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 25 PATIENTS. THE CASES IN THIS RANGE FROM 2010 AND 2012. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A PRECISE DEVICE(S) IDENTIFICATION OR PATIENT INFORMATION; HOWEVER, THE ARTICLE ALLEGES THAT 1 PATIENT EXPERIENCED HARDWARE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278274 UNKNOWN MATTA PLATE PLATE, FIXATION, BONE HRS STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention