BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR LOCK UPPER RETAINER

    MDR report key: 11634933 · Received April 8, 2021

    Report

    Report Number
    3011649314-2021-00106
    Event Type
    Injury
    Date Received
    April 8, 2021
    Report Date
    September 3, 2021
    Product Code
    DYJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION D4: THIS INFORMATION UPDATED AND CORRECTED AS IT WAS REPORTED INCORRECTLY AT THE INITIAL SUBMISSION. THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. SUPPLIER (ERKODENT) REVIEWED THE ASSOCIATED MATERIAL LOT AND CONFIRMED NO MANUFACTURING DEVIATION OR ABNORMALITY. LOT# ERKOD 1.0-11460 (ERKODUR) WAS MANUFACTURED FROM 08/24/20 AND WAS ASSIGNED WITH 3 YEARS EXPIRATION. STOCK PRODUCT REVIEWED RESULTS: NO STOCK PRODUCT WAS AVAILABLE FOR REVIEW SINCE THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. INVESTIGATION METHODS/RESULTS: COMPLAINT INVESTIGATOR VISUALLY INSPECTED THE RETURNED DEVICE. THE RETURNED PARTS INCLUDED BOTH UPPER AND LOWER TRAY IN A CLEARLOCK RETAINER CASE. THE RESULTS WERE SUMMARIZED: ROUGHNESS - THE EDGE WAS SMOOTH. CRACK - NO MAJOR CRACK/S WAS FOUND. DELAMINATION - LAYERS WERE INTACT AND DID NOT SEPARATE. DISCOLORATION - THE DEVICE WAS CLEAR WITH NO VISIBLE DISCOLORATION. GENERAL CLEANLINESS - THE RETURNED DEVICE APPEARED TO BE CLEAN, FREE OF DEBRIS OR FOREIGN PARTICLES. THE RETURNED DEVICE WAS VISUALLY INSPECTED, AND NO DEFECT OR ABNORMALITY WAS OBSERVED. THERE WAS NO EVIDENCE FOUND TO INDICATE THAT THE REPORTED ISSUE WAS CAUSED BY THE DEVICE ITSELF. ROOT CAUSE: A ROOT CAUSE FOR THIS COMPLAINT CANNOT BE EXPLICITLY DETERMINED. GLIDEWELL RESEARCH TEAM AND NAMSA CONDUCTED A SERIES OF TESTING ON A SIMILAR THERMOFORMED SLEEP DEVICE FOLLOWING ISO 10993 (BIOLOGICAL EVALUATION OF MEDICAL DEVICES) AND THE DEVICE WAS EVALUATED FOR POTENTIAL CYTOTOXICITY, SKIN IRRITATION, DELAYED DERMAL CONTACT SENSITIZATION AND ORAL MUCOSAL IRRITATION. THE TEST ARTICLE WAS THERMOFORMED WITH LAYERS OF ERKODENT MATERIAL (ERKOLOC-PRO AND ERKODUR). THE TEST RESULTS WERE LISTED BELOW AND SUMMARIZED IN BIOCOMPATIBILITY REPORT FOR SLEEP DEVICE (RPT 9733 REV 1.0) FOR CYTOTOXICITY TESTING, THE TEST ARTICLE EXTRACT SHOWED NO EVIDENCE OF CAUSING CELL LYSIS OR TOXICITY. FOR SKIN IRRITATION, THERE WAS NO ERYTHEMA AND NO EDEMA OBSERVED ON THE SKIN OF THE ANIMALS TREATED WITH THE TEST ARTICLE. FOR SENSITIZATION TESTING, THE TEST ARTICLE EXTRACTS SHOWED NO EVIDENCE OF CAUSING DELAYED DERMAL CONTACT SENSITIZATION. THE TEST ARTICLE SHOWED NONIRRITANT TO THE ORAL MUCOSA AS COMPARED TO THE CONTROL ARTICLE. THE DEVICE MATERIALS HAVE BEEN FOUND TO BE BIOCOMPATIBLE THROUGH THE TESTING. THERE WAS NO CYTOTOXIC, SENSITIZATION, SKIN IRRITATION, OR ORAL MUCOSAL IRRITATION FOUND IN ANY OF THE TEST ARTICLES.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE PATIENTS DATE OF BIRTH WAS NOT PROVIDED WHEN ASKED. THE PATIENTS WEIGHT IS NOT PROVIDED WHEN ASKED. THIS INFORMATION WAS NOT PROVIDED WHEN ASKED. IS NOT APPLICABLE WITH THE EXCEPTION OF SERIAL NUMBER AS THE DEVICE IS MANUFACTURED BY PRESCRIPTION IS NOT APPLICABLE AS THE DEVICE IS MANUFACTURED BY PRESCRIPTION NOT IMPLANTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534321 CLEAR LOCK UPPER RETAINER CLEAR LOCK UPPER RETAINER DYJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention