BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAINING 2.5MM HEX DRIVE R LATCHLOCK

    MDR report key: 6868643 · Received September 15, 2017

    Report

    Report Number
    0001038806-2017-00625
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Report Date
    October 31, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NDP
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    2023141-10-04-2017-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW IT WAS DETERMINED THAT THIS EVENT NO LONGER MEETS THE CRITERIA OF A MALFUNCTION IF WERE TO RECUR WOULD CAUSE OR CONTRIBUTED TO A DEATH AND / OR SERIOUS INJURY. AS A RESULT, THE PRIOR SUBMISSIONS FOR 0001038806-2017-00625 SUBMITTED ON SEPTEMBER 15, 2017 IS NO LONGER CONSIDERED REPORTABLE EVENTS BY THE MANUFACTURE AND NO FURTHER REPORTS WILL BE SUBMITTED FOR THIS EVENT. NO PRODUCT WAS RETURNED FOR INSPECTION. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: ¿INSTRUCTIONS FOR USE FOR SCREW-VENT® IMPLANTS¿ 9665 REV 0-09/14. ROTATE THE FIXTURE MOUNT/TRANSFER CLOCKWISE TO THREAD THE IMPLANT INTO PLACE. REMOVE THE INSERTION INSTRUMENTS. OPTIONAL: MAKE A STAGE-ONE, FULL-ARCH, ELASTOMERIC IMPRESSION USING THE FIXTURE MOUNT/TRANSFER AS A TRANSFER. ALTERNATIVELY, THE FIXTURE MOUNT/TRANSFER CAN BE REMOVED AND USED AS A TRANSFER AFTER THE HEALING PERIOD. INSERT THE 1.25MMD HEX DRIVER WITH GEMLOCK RETENTION [HXGR1.25, HXLGR1.25] INTO THE FIXTURE MOUNT/TRANSFER, UNTHREAD THE COUPLING SCREW AND REMOVE THE FIXTURE MOUNT/TRANSFER FROM THE IMPLANT. WHEN PLACING INTERNAL HEX IMPLANTS INTO DENSE BONE, THREAD THE IMPLANT INTO THE OSTEOTOMY UNTIL SLIGHT RESISTANCE IS ENCOUNTERED, THEN REMOVE THE FIXTURE MOUNT/TRANSFER AND COMPLETE SEATING WITH THE APPROPRIATE HEX DRIVER OR HEX DRILL [RH2.5, RHL2.5,RHD2.5]. ADDITIONALLY, THE FIXTURE MOUNT/TRANSFER CAN BE USED AS A TEMPORARY ABUTMENT FOR PROVISIONAL RESTORATIONS. FOR MORE DETAILED INSTRUCTIONS, PLEASE REFER TO THE TAPERED SCREW-VENT® AND SCREW-VENT IMPLANTS SURGICAL MANUAL #5161. A PRODUCT QUALITY HOLD (#133269) WAS ISSUED FOR THE AFFECTED LOTS WITHIN THE LOWER LEVEL LOT 63542171. HHED17-023 WAS INITIATED TO FURTHER EVALUATE A SIMILAR EVENT. AS A RESULT, HHE 2017-351 WAS INITIATED, AND CAPA (B)(4) WAS OPENED. CAPA (B)(4) WAS CLOSED TO SCAR 17038 FOR VERIDIAM ALLIED SWISS. SCAR 17038 WAS REVIEWED AND ADDRESSED THE REPORTED DEVICE MALFUNCTION. A PROBABLE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED, AS NO DEVICE WAS RETURNED FOR INSPECTION. COMPLAINT IS THEREFORE NON-VERIFIABLE.

    Additional Manufacturer Narrative · 1

    DEVICE LOT # WAS NOT PROVIDED/UNKNOWN. DEVICE HAS NOT BEEN RETURNED TO MANUFACTURE. PRODUCT NO RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HEX DRIVER (RHD2.5) IS TOO BIG TO FIT INTO THE FIXTURE MOUNT TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649969 RETAINING 2.5MM HEX DRIVE R LATCHLOCK HEX DRIVER NDP ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1