BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 3.7MM 10M M HEXAGON

    MDR report key: 8135212 · Received December 5, 2018

    Report

    Report Number
    0002023141-2018-00943
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Report Date
    April 10, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. WITHOUT THE RETURNED PRODUCT, THERE IS NOT ENOUGH EVIDENCE TO FORM A CONCLUSION ON THE REPORTED EVENT. THEREFORE, THE COMPLAINT IS NON-VERIFIABLE. A ROOT CAUSE CANNOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D3: MANUFACTURER. G2: MANUFACTURER'S CONTACT OFFICE. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE. THE FOLLOWING SECTION HAS BEEN CORRECTED: B5: EVENT DESCRIPTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREW FRACTURED INSIDE THE IMPLANT (SPMB10) WHEN THE PATIENT BIT DOWN. RETRIEVAL TOOLS 2223/2224 WERE REQUESTED. THE SCREW AND IMPLANT ARE BUNDLED TOGETHER UNDER THE IMPLANT ITEM NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL 510K NUMBERS: K011245 AND K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRANSFER MOUNT SCREW (SPMB10) FRACTURED INSIDE THE IMPLANT WHEN THE PATIENT BIT DOWN. RETRIEVAL TOOLS 2223/2224 WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975463 IMPL TAPERED SP 3.7MM 10M M HEXAGON DENTAL IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1