BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8842186 · Received July 30, 2019

    Report

    Report Number
    0002023141-2019-00485
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    June 27, 2019
    Report Date
    September 12, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 LOT (1221084) 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. 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

    ZIMMER BIOMET COMPLAINT (B)(4). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED. PMA/510(K) NUMBER: K011028, K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANT (TSVWB8) WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IT WAS ALSO REPORTED THAT BONE WERE HOLLOW INSIDE. IMPLANT DID NOT ACHIEVE PRIMARY STABILITY. SITE WAS BONE GRAFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636667 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL 1221084

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention