BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADAPTER FOR RATCHET L 18MM SHORT

    MDR report key: 3913936 · Received May 12, 2014

    Report

    Report Number
    1222315-2014-00003
    Event Type
    Other
    Date Received
    May 12, 2014
    Date of Event
    April 4, 2014
    Report Date
    May 9, 2014
    Manufacturer
    INSTITUT STRAUMANN AG,
    Product Code
    DZE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW OF ARTICLE 033.612S LOT GK715 INCLUDING THE SUBCOMPONENTS ARTICLE 307716 AND 307717 CONFIRMS THAT ALL MANUFACTURING, INSPECTION AND RELEASE ACTIVITIES MEET SPECIFICATION. THE DHR REVIEW OF ARTICLE 046.461 ADAPTER FOR RATCHET L 18MM LOT 1031 AND ARTICLE 046.470 HAND PIECE ADAPTER L 19 MM - EXTRA SHORT LOT A9191 CONFIRMS THAT ALL MANUFACTURING, INSPECTION AND RELEASE ACTIVITIES MEET SPECIFICATION. THE RETURNED 046.461 ADAPTER FOR RATCHET LOT 1031 AND 0463470 HAND PIECE ADAPTER LOT A9191 WERE EXAMINED IN DEVELOPMENT ENGINEERING. THE VISUAL INSPECTION OF ARTICLE 046.461 ADAPTER FOR RATCHET AND ARTICLE 046.470 HAND PIECE ADAPTER LOT A9191 SHOWS THERE ARE SIGNS OF EVERYDAY USE. PARTS WERE IN USE 10 YEARS AND 8 YEARS RESPECTIVELY. THE CRITICAL DIMENSIONS, WITH REGARD TO THE COMPLAINT, FOR BOTH ADAPTERS 046.461 AND 46.470 WERE MEASURED AND CORRESPOND TO THE DEFINED. SPECIFICATIONS. A REVIEW OF THE RISK MANAGEMENT REPORT HAS IDENTIFIED THE HAZARD "ASPIRATION". THE APPROPRIATE INFORMATION THAT PRODUCTS MUST BE SECURED AGAINST ASPIRATION WHEN HANDLED INTRA-ORALLY IS PUBLISHED UNDER WARNINGS AND CAUTIONS IN THE IFU 70135 FOR IMPLANTS. IFU 701124 NON-STERILE SURGICAL INSTRUMENTS AND BROCHURE 152.754 "BASIC INFORMATION ON THE SURGICAL PROCEDURE". THE FUNCTIONAL USE CARE TEST USING BOTH RETURNED ADAPTERS 046.461 AND 046.470 TOGETHER WITH IMPLANTS FROM THE SAME MANUFACTURING LOT AS REPORTED IN THIS EVENT CONFIRMED THAT BOTH ADAPTERS FUNCTION AS INTENDED. THEREFORE WE CAN CONCLUDE THAT THERE IS NO PRODUCT IMPLANT, RATCHET ADAPTER, AND HAND PIECE ADAPTER ISSUE WHICH HAS A CONTRIBUTING CAUSE TO THIS INCIDENT.

    Description of Event or Problem · 1

    THE SPECIALIST PROSTHODONTIST REPORTS THAT HE PLACED A DENTAL IMPLANT 033.612S LOT GK715 IN THE UPPER MOLAR SITE DRI #16 ON (B)(6) 2014 WHEN THE LOXIM TRANSFER PIECE FAILED TO LOCATE THE ADAPTER WHILST IN IMPLANT CARRIER; FAILED TO DISENGAGE FROM IMPLANT ONCE INSERTED USING HAND PIECE ADAPTER. MANUAL ADAPTER HAD TO BE USED WHICH DID NOT LOCATE EASILY INTO ADAPTER TO BECAME UNLOCKED AND LOXIM TRANSFER PIECE TRAVELLED INTO PATIENT'S LUNG. PATIENT HAD UNDUE STRESS, REQUIRED BRONCHOSCOPE INVESTIGATION TO RETRIEVE FOREIGN OBJECT. PATIENT SPENT TWO DAYS IN HOSPITAL (FACILITY NAME NOT REPORTED) AND ALMOST REQUIRED A GENERAL ANAESTHETIC. UPDATED INFORMATION TO INCIDENT WAS PROVIDED BY THE SPECIALIST PROSTHODONTIST ON (B)(6) 2014 DURING TELEPHONE CONVERSATION WITH HEAD OF PRODUCT DEVELOPMENT, (B)(4) AND RECORDED IN REPORT DATED (B)(6) 2014. SPECIALIST PROSTHODONTIST USED THE HAND PIECE WITH THE 046.470 HAND PIECE ADAPTER L 19MM - EXTRA SHORT LOT A9191 TO REMOVE THE IMPLANT FROM THE IMPLANT CARRIER. IT DID NO FULLY ENGAGE (DID NOT CLICK-IN) WITH THE LOXIM TRANSFER PIECE BUT HE DID REMOVE THE IMPLANT 033.612S LOT GK715. THE IMPLANT WAS INSERTED IN UPPER MOLAR SITE #16 TO ITS FINAL POSITION. THE HAND PIECE ADAPTER 046.470 WAS REMOVED. AS THE HAND PIECE ADAPTER WAS NOT PROPERLY ENGAGED TO THE LOXIM TRANSFER PIECE, THE LOXIM STAYED IN THE IMPLANT. THE SPECIALIST PROSTHODONTIST THEN USED THE 046.461 ADAPTER FOR RATCHET L 18MM - SHORT LOT 1031 TO REMOVE THE LOXIM TRANSFER PIECE FROM THE IMPLANT BUT WAS NOT ABLE TO ENGAGE IT PROPERLY. HE REMOVED THE RATCHET ADAPTER FROM THE PATIENT'S MOUTH. HE MADE A SECOND ATTEMPT USING THE RATCHET ADAPTER 046.461 DURING WHICH THE RATCHET ADAPTER 046.461 SLIPPED OFF HIS HAND AND TRAVELLED INTO THE PATIENT'S LUNG. HE THEN ENGAGED THE HAND PIECE ADAPTER 046.470 TO THE LOXIM TRANSFER PIECE AND USING THE RELEASE AID 026.4558 HE SUCCESSFULLY REMOVED THE LOXIM FROM THE IMPLANT. THE PATIENT WAS SUBSEQUENTLY SENT TO HOSPITAL WHERE HE STAYED FOR TWO DAYS. A DIAGNOSIS WAS DONE AND A SURGICAL INTERVENTION WAS PLANNED TO REMOVE THE 046.461 RATCHET ADAPTER FROM HIS LUNG. ON THE SEONCD DAY OF THE HOSPITAL STAY, THE PATENT WAS ABLE TO COUGH OUT THE RATCHET ADAPTER 046.461 HIMSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283424 ADAPTER FOR RATCHET L 18MM SHORT DENTAL IMPLANT ACCESSORY DZE INSTITUT STRAUMANN AG, 1031

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization NTP LOT GK715 AND 046.470 HAND PIECE ADAPTER| 033.612S SP 4.8 WN| L 19MM - EXTRA SHORT LOT A9191| SLACTIVE, 10MM TIZR