BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAHN TAPERED IMPLANT 5.0 X 8 MM

    MDR report key: 17135374 · Received June 15, 2023

    Report

    Report Number
    3011649314-2023-00403
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    April 28, 2023
    Report Date
    November 3, 2023
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT# 6130165 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: A REVIEW OF STOCK PRODUCT WAS PERFORMED FOR HAHN TAPERED IMPLANT LOT# 6130165 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN THE ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE A HAHN TAPERED IMPLANT Ø5.0 X 8 MM (PART# 70-1154-IMP0014) USING RADIOGRAPHIC TEMPLATE (PK-209-062515). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. THE COMPLAINT IS VERIFIED BASED ON THE RETURNED PART BUT CANNOT CONFIRM THE FAILURE MODE. THERE WAS NO EVIDENCE FOUND THAT INDICATED THAT THE REPORTED ISSUE WAS CAUSED BY THE DEVICE ITSELF. ROOT CAUSE: A ROOT CAUSE FOR THIS COMPLAINT CANNOT BE EXPLICITLY DETERMINED. PROBABLE ROOT CAUSE IS THE OVER-TORQUING OF THE IMPLANT DURING THE INITIAL PLACEMENT WHICH MAY HAVE CAUSED A TIGHT FIT. ADDITIONALLY, IT IS UNCLEAR THE METHODS OF IMPLANT PLACEMENT USED DURING THE INITIAL PROCEDURE AND THE INSERTION TORQUE VALUE. IFU-6538 REV 5.0 (HAHN TAPERED IMPLANT GUIDED SURGERY SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE IMPLANT PLACEMENT SECTION: "STEP 1: IMPLANT SELECTION - REMOVE THE TITANIUM IMPLANT HOLDER FROM ITS PACKAGING AND PLACE IT ONTO A STERILE FIELD. NOTE: THE PLASTIC TRAY CONTAINS A COVER SCREW, FOR USE WHEN FOLLOWING A TWO-STAGE SURGICAL PROTOCOL. DO NOT DISCARD THE COVER SCREW UPON REMOVAL OF THE IMPLANT. ENGAGE THE IMPLANT CONNECTION WITH THE APPROPRIATE IMPLANT MOUNT. FASTEN THE ASSEMBLY USING THE SCREW CAPTURED IN THE IMPLANT MOUNT. WITH THE IMPLANT SECURELY ATTACHED TO THE MOUNT, SQUEEZE THE OPPOSING END OF THE HOLDER TO DISENGAGE THE IMPLANT FROM THE HOLDER. STEP 2: INITIAL PLACEMENT - TRANSPORT THE IMPLANT TO THE PREPARED SITE, THEN INSERT IT THROUGH THE GUIDE AND INTO THE OSTEOTOMY. ROTATE CLOCKWISE WITH APPLIED PRESSURE TO ENGAGE THE SELF-TAPPING GROOVES. STEP 3: ADVANCEMENT AND FINAL SEATING - ASSEMBLE THE RATCHET WRENCH WITH THE SURGICAL ADAPTOR. WITH THE IMPLANT SECURED TO THE IMPLANT MOUNT, SEAT THE ADAPTOR ATOP THE MOUNT AND ENGAGE THE CONNECTION. TURN THE WRENCH CLOCKWISE IN INCREMENTS OF APPROXIMATELY 90 DEGREES. CONTINUE THREADING THE IMPLANT INTO THE OSTEOTOMY SITE UNTIL THE HEX FLANGE ON THE IMPLANT MOUNT MEETS THE HEX OF THE GUIDE SLEEVE. ADJUST THE FINAL POSITION OF THE IMPLANT BY ALIGNING THE HEX ON THE IMPLANT MOUNT WITH THE HEX OF THE GUIDE SLEEVE. THIS WILL ALLOW THE RESTORING CLINICIAN TO TAKE FULL ADVANTAGE OF THE ANATOMICAL ABUTMENT CONTOURS AND MINIMIZE THE NEED FOR ABUTMENT PREPARATION. A MINIMUM TORQUE VALUE OF 35 NCM UPON FINAL SEATING INDICATES GOOD PRIMARY STABILITY."

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS II. THERE IS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT PLACEMENT. THE PATIENT PRESENTED ON (B)(6) 2023 FOR A PRIMARY PROCEDURE ON TOOTH #30. DURING PLACEMENT, THE PROVIDER NOTED THAT THE "HAND-PLACED IMPLANT AND MOUNT WOULD NOT SEPARATE FROM THE IMPLANT AFTER PLACEMENT." THE PROVIDER HAD TO REVERSE THE IMPLANT OUT WITH A WRENCH. THE PATIENT'S CURRENT STATUS IS NOTED AS GOOD AND THAT A REPLACEMENT IMPLANT IS SCHEDULED FOR A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839066 HAHN TAPERED IMPLANT 5.0 X 8 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0014 6130165

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female