BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM INSTR

    MDR report key: 12011233 · Received June 16, 2021

    Report

    Report Number
    3003604053-2021-00229
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    December 29, 2020
    Report Date
    November 5, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    OWY
    PMA / PMN Number
    K140300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). B5: DESCRIPTION UPDATED.

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. AN ANALYSIS OF THE CUSTOMER PROVIDED IMAGE FOUND A SMALL PIECE OF WHITE MATERIAL. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. CLINICAL EVALUATION FOUND THAT NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER PROCEDURE, THE PATIENT WAS EXPERIENCING IRRITATION AND SWELLING. THE SURGEON ORDERED AND MRI WHERE A FOREIGN BODY WAS RECOGNIZED. PATIENT UNDERWENT SURGERY WHERE THE LOOSE REGENETEN WAS RECOVERED AND SHOULDER FLUSHED OUT. CURRENT STATUS OF THE PATIENT IS FULLY RECOVERED.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PROCEDURE, THE PATIENT WAS EXPERIENCING IRRITATION AND SWELLING. THE SURGEON ORDERED AND MRI WHERE A FOREIGN BODY WAS RECOGNIZED. PATIENT UNDERWENT SURGERY WHERE THE LOOSE REGENETEN WAS RECOVERED. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907995 UNKN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM INSTR MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON OWY SMITH & NEPHEW, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O