BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø3.0 X 11.5 MM

    MDR report key: 16573052 · Received March 20, 2023

    Report

    Report Number
    3011649314-2023-00153
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    February 14, 2023
    Report Date
    February 6, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CAPA 2023-006 THE DEVICE HAS NOT BEEN RETURNED. HOWEVER, THE NON-VISUAL DEVICE EVALUATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS THE DHR WAS REVIEWED FOR LOT # 6113521 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 REVIEWED RESULTS THERE WAS NO STOCK PRODUCT FROM LOT # 6113521 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS THE CUSTOMER HAS NOT RETURNED THE COMPLAINT PART FOR INVESTIGATION TO DATE. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE THE ROOT CAUSE WAS INCONCLUSIVE AND CANNOT BE EXPLICITLY DETERMINED. THE PROBABLE CAUSE FOR THE FRACTURE COULD BE CONTRIBUTED BY USER/PATIENT FACTORS. IFU-570 REV 3 (HAHN TAPERED IMPLANT SYSTEM IFU). FOR BEST RESULTS, PLEASE OBSERVE THE FOLLOWING PRECAUTIONS: ALL DRILLING PROCEDURES SHOULD BE PERFORMED AT 2000 RPM OR LESS UNDER CONTINUAL, COPIOUS IRRIGATION. ALL SURGICAL INSTRUMENTS USED MUST BE IN GOOD CONDITION AND SHOULD BE USED CAREFULLY TO AVOID DAMAGE TO IMPLANTS OR OTHER COMPONENTS. IMPLANTS SHOULD BE PLACED WITH SUFFICIENT STABILITY; HOWEVER, EXCESSIVE INSERTION TORQUE MAY RESULT IN IMPLANT FRACTURE, OR FRACTURE OR NECROSIS OF THE IMPLANT SITE. THE PROPER SURGICAL PROTOCOL SHOULD BE STRICTLY ADHERED TO. SINCE IMPLANT COMPONENTS AND THEIR INSTRUMENTS ARE VERY SMALL, PRECAUTIONS SHOULD BE TAKEN TO ENSURE THAT THEY ARE NOT SWALLOWED OR ASPIRATED BY THE PATIENT. PRIOR TO SURGERY, ENSURE THAT THE NEEDED COMPONENTS, INSTRUMENTS, AND ANCILLARY MATERIALS ARE COMPLETE, FUNCTIONAL AND AVAILABLE IN THE CORRECT QUANTITIES.

    Additional Manufacturer Narrative · 0

    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 COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES. PATIENT'S RACE WAS ASKED BUT NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    CAPA CA-00016. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS III AND THEIR ORAL HYGIENE IS GOOD. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2023 FOR A PRIMARY PROCEDURE ON TOOTH #5. THE PATIENT RETURNED ON (B)(6) 2023, WITHIN THREE WEEKS OF IMPLANT PLACEMENT WITHOUT COMPLAINTS. UPON EXAMINATION, THE PROVIDER NOTED THE SCREW FRACTURE INSIDE THE IMPLANT AND THE DEVICE WAS REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS III AND THEIR ORAL HYGIENE IS GOOD. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2023 FOR A PRIMARY PROCEDURE ON TOOTH #5. THE PATIENT RETURNED ON (B)(6) 2023, WITHIN THREE WEEKS OF IMPLANT PLACEMENT WITHOUT COMPLAINTS. UPON EXAMINATION, THE PROVIDER NOTED THE SCREW FRACTURE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT "THE COVER SCREW SNAPPED INSIDE THE IMPLANT, REQUIRING THE IMPLANT TO BE REMOVED BECAUSE THE FRACTURED COVER SCREW COULD NOT BE RETRIEVED AND THE IMPLANT COULD NOT BE RESTORED." THE IMPLANT WAS REPLACED WITH A PRODUCT SIMILAR TO THE COMPLAINT PRODUCT AND NO ADDITIONAL MEDICAL/SURGICAL PROCEDURE WAS REQUIRED. THERE WAS NO PERMANENT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976211 HAHN TAPERED IMPLANT Ø3.0 X 11.5 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0001 6113521

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention