MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ TAPERED CERTAIN¿ PREVAIL¿ IMPLANT 4/3 X 8.5MM; DENTAL IMPLANT

Model Number	XIITP4385
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Osteolysis (2377)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient weight unknown / not provided.Event date of event 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 nonexistent.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 implant at tooth #15 was placed 1 year ago and were removed due to inflammation, infection and bone loss.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: the initial report, mfr report number 0001038806-2023-00567 is a duplicate of mfr report number 0001038806-2023-00563 that was submitted on march 23, 2023.Therefore, this supplemental mw is being submitted as a retraction due to duplication of mfr report number 0001038806-2023-00563.No additional reports will be submitted under mfr report number 0001038806-2023-00567.
Event or Problem Description
This report is being submitted to retract the initial report, mfr report number 0001038806-2023-00567 as this event has already been submitted and is a duplicate of mfr report number 0001038806-2023-00563 that was submitted on march 23, 2023.

• Brand Name: OSSEOTITE¿ TAPERED CERTAIN¿ PREVAIL¿ IMPLANT 4/3 X 8.5MM
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16609868
• Report Number: 0001038806-2023-00567
• Device Sequence Number: 20028031
• Product Code: DZE
• UDI-Device Identifier: 00844868022107
• UDI-Public: (01)00844868022107(17)260517(10)2021050226
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• 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): 04/24/2023

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: 05/17/2026
• Device Model Number: XIITP4385
• Device Catalogue Number: XIITP4385
• Device Lot Number: 2021050226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2021
• 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: 66 YR
• Patient Sex: Male