BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

    MDR report key: 8699690 · Received June 14, 2019

    Report

    Report Number
    0002023141-2019-00272
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    April 9, 2019
    Report Date
    July 8, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    SIMILAR COMPLAINTS FOR THE INABILITY TO ACHIEVE PRIMARY STABILITY (UNABLE TO PLACE IMPLANT INTO OSTEOTOMY) HAVE BEEN PREVIOUSLY INVESTIGATED. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PREVIOUSLY RETURNED PRODUCT HAVE NOT IDENTIFIED OR SUGGESTED MANUFACTURING NON-CONFORMANCES. WHILE NON-CONFORMANCES WERE IDENTIFIED FOR SOME LOTS DURING MANUFACTURING RECORDS REVIEWS, THE DOCUMENTED DISPOSITION ACTIONS FOR EACH HAVE NOT SUGGESTED THE LIKELY RELEASE OF NON-CONFORMING PRODUCT. TO DATE, ALL COMPLAINT DATA WAS FOUND TO BE CONFORMING AND DID NOT MEET CAPA/HHE/D/IE ESCALATION. THEREFORE, THERE WERE NO COMPLAINTS WHICH CONFIRMED A MANUFACTURING OR DESIGN RELATED ISSUE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE SUBJECT LOT (1220397) DID NOT IDENTIFY ANY RELATED NON-CONFORMANCES WHICH WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ADDITIONALLY, THERE HAVE BEEN NO RELATED COMPLAINTS REPORTED AGAINST THE SUBJECT LOT. THESE FACTS DO NOT SUGGEST A SYSTEMIC QUALITY ISSUE WITH THE LOT. REPORTED EVENTS LIKELY EXIST OUTSIDE OF ZIMMER BIOMET CONTROL, INCLUDING THOSE RELATED TO PATIENT BIOLOGICAL FACTORS/CONDITION AND SURGICAL TECHNIQUE. A ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED AS THE EVENT CANNOT BE RECREATED. COMPLAINT IS THEREFORE NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: D4: (B)(4).

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT'S WEIGHT NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBERS: K011028 AND K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT (TSVWB8) DID NOT ACHIEVE PRIMARY STABILITY IN THE BONE. NO OTHER IMPLANT WAS ABLE TO BE PLACED DURING THE SAME PROCEDURE. THE WOUND WAS CLOSED AND AWAITING HEALING FOR NEW IMPLANT PLACEMENT. TOOTH LOCATION 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495493 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL 1220397

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention