BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,MCOL MG,4.1MM,11M

    MDR report key: 8900793 · Received August 16, 2019

    Report

    Report Number
    0002023141-2019-00574
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    March 1, 2019
    Report Date
    September 18, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 LOTS (1220434) DID NOT IDENTIFY ANY RELATED NON-CONFORMANCES WHICH WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ADDITIONALLY, THERE HAS BEEN ONE (1) RELATED COMPLAINT REPORTED AGAINST THE SUBJECT LOT. INVESTIGATION HAS IDENTIFIED THAT THE PROBABLE CAUSES ARE RELATED TO PATIENT BIOLOGICAL FACTORS/CONDITION AND SURGICAL TECHNIQUE. THESE FACTS DO NOT SUGGEST A SYSTEMIC QUALITY ISSUE WITH THE LOT. AS DOCUMENTED IN THE SUMMARY INVESTIGATION, CONTRIBUTING FACTORS FOR THESE REPORTED EVENTS LIKELY EXIST OUTSIDE OF ZIMMER BIOMET CONTROL, INCLUDING THOSE RELATED TO PATIENT BIOLOGICAL FACTORS/CONDITION AND SURGICAL TECHNIQUE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: D4: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANT (TSVM4B11) WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT DID NOT ACHIEVE PRIMARY STABILITY. SITE WAS BONE GRAFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696313 IMP,TSV,MCOL MG,4.1MM,11M DENTAL IMPLANT DZE ZIMMER DENTAL 1220434

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention