BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM

    MDR report key: 8713086 · Received June 19, 2019

    Report

    Report Number
    0002023141-2019-00302
    Event Type
    Injury
    Date Received
    June 19, 2019
    Date of Event
    May 15, 2019
    Report Date
    July 11, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. REFER TO ATTACHED SUMMARY INVESTIGATION. 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 (1220153) 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: B4: DATE OF THIS REPORT, G4: DATE RECEIVED BY MANUFACTURER, G7: CHECKED "FOLLOW-UP", H2: CHECKED FOLLOW-UP TYPE, H3: DEVICE EVALUATED BY MANUFACTURER, H6: ENTERED EVALUATION CODES, H10: ADDED MANUFACTURER NARRATIVE.

    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 IDENTIFIER: NOT PROVIDED. AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED. INITIAL REPORTER FAX NUMBER: NOT PROVIDED. UDI NUMBER: (B)(4). PMA/510(K) NUMBER: K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANT (TSVWB11) WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT WAS REMOVED AND SITE WAS GRAFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504133 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 1220153

    Patients

    Seq Age Sex Outcome Treatment
    1