BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBUNION

    MDR report key: 11730330 · Received April 27, 2021

    Report

    Report Number
    3011421599-2021-00003
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    December 4, 2020
    Report Date
    March 24, 2021
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    PMA / PMN Number
    K190658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR COMMUNICATED THAT DR. (B)(6) HAD 3 POTENTIAL INFECTIONS OCCURRED WITH MINIBUNION USAGE. THE SURGEON CONFIRMED THAT ONE OF CASES PERFORMED ON (B)(6) 2020 EXPERIENCED DELAYED HEALING, EDEMA AND TOOK ORAL ANTIBIOTICS. TWO (2) CASE REPORTS ARE FROM (B)(6) 2020 AS IT IS UNCLEAR WHICH CASE EXPERIENCED THIS EVENT. THE SURGEON EXPRESSED THAT DURING THE PROCEDURE CONTROL OF THE CAPITAL FRAGMENT WAS DIFFICULT AND THE BONE CORTEX MAY NOT HAVE BEEN SMOOTH CAUSING SOFT TISSUE IRRITATION AS THERE IS NOT A LOT OF TISSUE OVER THE SURGICAL SITE. THE HARDWARE WAS NOT REMOVED, AND HEALING OCCURRED APPROXIMATELY 6 WEEKS POST-OPERATIVELY.. THE PART NUMBER AND LOT NUMBER ASSOCIATED WITH THE EVENT IS UNKNOWN. THE SURGEON PERFORMED 4 CASES; 3 CASES INCLUDED A SINGLE LOT. PART NUMBER 3100-2716NL LOT 510023 WITH AVAILABLE PARTS. CYTOTOXICITY, ENDOTOXIN AND BIOBURDEN TESTING WAS PERFORMED AND MET ACCEPTANCE CRITERIA.

    Description of Event or Problem · 0

    THE DISTRIBUTOR COMMUNICATED THAT DR. (B)(6) HAD 3 POTENTIAL INFECTIONS OCCURRED WITH MINIBUNION USAGE. THE SURGEON CONFIRMED THAT ONE OF CASES PERFORMED ON (B)(6) 2020 EXPERIENCED DELAYED HEALING, EDEMA AND TOOK ORAL ANTIBIOTICS. TWO (2) CASE REPORTS ARE FROM (B)(6) 2020 AS IT IS UNCLEAR WHICH CASE EXPERIENCED THIS EVENT. THE SURGEON EXPRESSED THAT DURING THE PROCEDURE CONTROL OF THE CAPITAL FRAGMENT WAS DIFFICULT AND THE BONE CORTEX MAY NOT HAVE BEEN SMOOTH CAUSING SOFT TISSUE IRRITATION AS THERE IS NOT A LOT OF TISSUE OVER THE SURGICAL SITE. THE HARDWARE WAS NOT REMOVED, AND HEALING OCCURRED APPROXIMATELY 6 WEEKS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626816 MINIBUNION PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention