BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTRON CLEAR SPLINTS

    MDR report key: 10224766 · Received July 2, 2020

    Report

    Report Number
    3011649314-2020-00564
    Event Type
    Injury
    Date Received
    July 2, 2020
    Report Date
    November 11, 2020
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    MQC
    PMA / PMN Number
    K111828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS NO DHR WAS AVAILABLE FOR REVIEW. THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. STOCK PRODUCT REVIEWED RESULTS NO STOCK PRODUCT WAS AVAILABLE FOR REVIEW SINCE THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. INVESTIGATION METHODS/RESULTS THE RETURNED PARTS INCLUDED AN UPPER TRAY IN AN ORIGINAL CASE. THE RESULTS WERE SUMMARIZED BELOW. ROUGHNESS - THE EDGE WAS SMOOTH AND POLISHED. CRACK - NO MAJOR CRACKS WERE FOUND. DELAMINATION - LAYERS WERE INTACT AND DID NOT SEPARATED. DISCOLORATION - NO DISCOLORATION WAS OBSERVED. GENERAL CLEANLINESS - THE DEVICE WAS CLEAN. CASE WAS RETURNED IN A GOOD CONDITION WITH LABEL ROOT CAUSE THE ROOT CAUSE CANNOT BE EXPLICITLY DETERMINED. CUSTOMER PROVIDED VERY LIMITED INFORMATION FOR THIS COMPLAINT. IT WAS UNKNOWN WHAT TYPE OF REACTION THE PATIENT HAD SPECIFICALLY. PER PREMARKET NOTIFICATION 510(K) SUMMARY FOR CLEARSPLINT (K111828), IT CONTAINED THE FOLLOWING STATEMENT IN PROPOSED INSTRUCTION: "CAUTION: AN ALLERGY TEST IS RECOMMENDED PRIOR TO PLACING (APPLIANCE) IN A DENTAL CAVITY." HOWEVER, IT WAS UNKNOWN IF ANY DENTAL OR MEDICAL HISTORY WAS PROVIDED BY THE PATIENT PRIOR TO THE DEVICE WAS PRESCRIBED. IN ADDITION, IT WAS UNKNOWN HOW PATIENT WAS INSTRUCTED TO MAINTAIN AND CLEAN THE DEVICE. PER PROPOSED INSTRUCTION PROVIDED FROM K111828, ASTRON DENTAL CORPORATION SUGGESTED "BRIEFLY PLACE APPLIANCE IN WARM TAP WATER BEFORE INSERTING IN MOUTH." PER SUPPLEMENT DATA FROM K111828, THE CLEARSPLINT WAS FOUND TO BE BIOCOMPATIBLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. IF/WHEN THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS INFORMATION NOT PROVIDED WHEN ASKED. THIS INFORMATION NOT PROVIDED WHEN ASKED. THIS INFORMATION NOT PROVIDED WHEN ASKED. THIS INFORMATION NOT PROVIDED WHEN ASKED. IS NOT APPLICABLE WITH THE EXCEPTION OF LOT 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 A REACTION TO THE ASTRON CLEAR SPLINT. THERE IS NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689113 ASTRON CLEAR SPLINTS ASTRON CLEAR SPLINTS  MQC PRISMATIK DENTALCRAFT, INC. 1106433046

    Patients

    Seq Age Sex Outcome Treatment
    1