MAUDE Adverse Event Report: BIOMET 3I EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH

Catalog Number	CT3111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.H3 other text : summary investigation.
Event or Problem Description
It was reported that the patient had the implant at tooth location #11 placed at another office in july 2023.Before that, the tooth was removed and no bone graft was placed.The patient was seen for pain and swelling around the implant at site #11.The implant remained implanted and the patient was given amoxicillin due to infection.Symptoms as a result of the event: pain.Swelling.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: the initial report, mfr report number 0001038806-2024-01296 that was submitted on june 20, 2024 was submitted in error under the wrong manufacturing site.This event was initially created/submitted to fda under complaint number, (b)(4) on 6/202/24 under the wrong mfr number (0001038806-2024-01296).To correct the error, a new complaint (b)(4) was opened and this event was reported under the correct mfr number (0002023141-2024-02137).Therefore, all details related to this event will be captured under the new complaint (b)(4), mfr number (0002023141-2024-02137).The following sections have been updated: b4: date of this report.B5: event information was updated.G3: date received by manufacturer.H2: type of follow-up was updated.H10: manufacturer narrative was updated.
Event or Problem Description
This supplemental is being reported as a correction.This event was initially created/submitted to fda under complaint number, (b)(4) on 6/202/24 under the wrong mfr number (0001038806-2024-01296).To correct the error, a new complaint (b)(4) was opened and this event was reported under the correct mfr number (0002023141-2024-02137).Therefore, all details related to this event will be captured under the new complaint (b)(4), mfr number (0002023141-2024-02137).

• Brand Name: EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19574216
• Report Number: 0001038806-2024-01296
• Device Sequence Number: 19828475
• Product Code: DZE
• UDI-Device Identifier: 00889024343887
• UDI-Public: (01)00889024343887(17)280419(10)1266118
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K142082
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CT3111
• Device Lot Number: 1266118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic