BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT 3.5X13MM

    MDR report key: 10323016 · Received July 24, 2020

    Report

    Report Number
    3011649314-2020-00569
    Event Type
    Injury
    Date Received
    July 24, 2020
    Date of Event
    February 26, 2020
    Report Date
    January 22, 2021
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: INVESTIGATION METHODS/RESULTS: CUSTOMER DID NOT RETURN THE IMPLANT FOR INSPECTION. DEVICE HISTORY RECORD REVIEW: THE DHR WAS REVIEWED AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. THE PART MET ALL THE CRITERIA CALLED FOR IN THE PRODUCTION ROUTER. STOCK PRODUCT REVIEW: NO STOCK PRODUCT FROM THE REPORTED LOT# 6040295 WAS AVAILABLE FOR REVIEW. ROOT CAUSE: THE ROOT CAUSE CANNOT BE EXPLICITLY DETERMINED. CUSTOMER DID NOT RETURN THE IMPLANT FOR INVESTIGATION. CUSTOMER DID NOT REPORT ANY ISSUE WITH THE IMPLANT. IN ADDITION, CUSTOMER DID NOT REPORT ANY STABILITY ISSUE MIGHT BE POSSIBLY CAUSING THE INFECTION.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S WEIGHT WAS ASKED, BUT WAS NOT PROVIDED BY THE CUSTOMER. (EXPIRATION DATE AND UDI) IF/WHEN THIS INFORMATION IS PROVIDED A MEDWATCH FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF/WHEN THIS INFORMATION IS RECEIVED A MEDWATCH FOLLOW-UP REPORT WILL BE SUBMITTED THE DEVICE HAS NOT BEEN RETURNED. WHEN/IF THE DEVICE IS RETURNED FOR EVALUATION, THE NEW INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAHN TAPERED IMPLANT FAILED. THE IMPLANT WAS PLACED ON (B)(6) 2020 AT TOOTH LOCATION #22. THE PATIENT RETURNED ON (B)(6) 2020 COMPLAINING OF PAIN. AFTER EXAMINATION, THE DOCTOR NOTED THAT THERE WAS INFECTION AT THE IMPLANT SITE. IT WAS AT THAT TIME THAT THE IMPLANT WAS REMOVED. THE PATIENT'S PAIN DISAPPEARED AFTER THE IMPLANT WAS REMOVED. THE PATIENT WAS TYPE II BONE QUALITY, AND HAS NO RELATIVE MEDICAL OR DENTAL HISTORY. THERE WAS NO ABNORMALITY NOTED WITH THE IMPLANT ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787757 HAHN TAPERED IMPLANT 3.5X13MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0007 6040295

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention