BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PROFYLE HAND 1.7 MM NON-LOCKING HOOK PLATE

    MDR report key: 15473242 · Received September 23, 2022

    Report

    Report Number
    0008031020-2022-00468
    Event Type
    Injury
    Date Received
    September 23, 2022
    Date of Event
    March 16, 2021
    Report Date
    September 22, 2022
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS IDENTIFIED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW PUBLISHED BY THE ¿DEPARTMENT OF ORTHOPEDIC SURGERY, CHINA MEDICAL UNIVERSITY HOSPITAL, TAIWAN¿. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1186/S12891-021-04163-2. THE REPORTED EVENT 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'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE.   IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT OF ORTHOPEDIC SURGERY, CHINA MEDICAL UNIVERSITY HOSPITAL, TAIWAN¿. THE TITLE OF THIS REPORT IS ¿FUNCTIONAL OUTCOMES AND COMPLICATIONS OF HOOK PLATE FOR BONY MALLET FINGER: A RETROSPECTIVE CASE SERIES STUDY¿, PUBLISHED ON MARCH 16, 2021, AND CAN BE FOUND AT HTTPS://DOI.ORG/10.1186/S12891-021-04163-2. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿PROFYLE HAND SYSTEM¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 16 PATIENTS. THE CASES IN THIS STUDY RANGE FROM JANUARY 2015 TO JULY 2020. 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 NAIL DEFORMITY, WHICH REQUIRED IMPLANT REMOVAL. THE REPORT STATES, ¿ONE PATIENT COMPLAINED OF PATIENT'S NAIL DEFORMITY, AND THE PLATE WAS REMOVED 6 MONTHS AFTER THE OPERATION¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2728667 UNKNOWN PROFYLE HAND 1.7 MM NON-LOCKING HOOK PLATE PLATE, FIXATION, BONE HRS STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention