MAUDE Adverse Event Report: ZIMMER DENTAL 3I T3 WITH DCD TAPERED IMPLANT 6/5 X 10MM; DENTAL IMPLANT

Catalog Number	BNPT6510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A4: weight unknown / not provided.A summary investigation has been completed for bone loss and infection events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for bone loss and infection have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost non-existent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
It was reported that the implant at tooth location #3 was removed due to infection and bone loss.Symptoms as a result of the event: abscess.
Additional Manufacturer Narrative
This medwatch report is being submitted as a correction report to replace mfr report# 0002023141-2023-02871 that was submitted on 10/12/2023 in error under the incorrect report number.This event was initially created/submitted to fda under complaint number, (b)(4) on 10/12/2023 under the wrong mfr number (0002023141-2023-02871).Complaint (b)(4)/mfr number (0002023141-2023-02871 will be voided as a duplicate of (b)(4)/mfr number 0001038806-2023-02002 and all details and information associated with this event will be documented under cmp-23500-2023/mfr number 0001038806-2023-02002.
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 10/12/23 under the wrong mfr number (0002023141-2023-02871).To correct the error, a new complaint (b)(4) was opened and this event was reported under the correct mfr number (0001038806-2023-02002).Therefore, all details related to this event will be captured under the new complaint (b)(4), mfr number (0001038806-2023-02002).

• Brand Name: 3I T3 WITH DCD TAPERED IMPLANT 6/5 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 17918878
• Report Number: 0002023141-2023-02871
• Device Sequence Number: 6782645
• Product Code: DZE
• UDI-Device Identifier: 00844868029502
• UDI-Public: (01)00844868029502(17)220321(10)2017030240
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• 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): 10/17/2023

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: Lay User/Patient
• Device Expiration Date: 03/20/2022
• Device Catalogue Number: BNPT6510
• Device Lot Number: 2017030240
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2023
• 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: 10/12/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2017
• 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: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic