MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® CERTAIN® IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Model Number	IOSS411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sinus Perforation (2277); Osteolysis (2377)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant lost integration due to peri-implantitis at the implant site.The implant had moved into sinus with significant sinus disease present.Buccal bone loss on the buccal as well around implant.The implant was subsequently removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The reported device was returned for investigation.Visual evaluation of the returned product identified no apparent malfunction with the implant.Signs of use were present.Product matched print specification when measured.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.It was noted on the product experience report (per) that the patient has (moderate density) type ii bone.The reported device was being placed on tooth # 13 and was used for approximately 11 months and 23 days.The customer did not provide any pictures or x-rays.A device history record (dhr)review was performed and no related deviations or nonconformance's were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Complainant reported that the implant lost integration due to peri-implantitis at the implant site and that the implant had moved into sinus.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes' h6: evaluation codes,.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE® CERTAIN® IMPLANT 4 X 11.5MM
• 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: 12358399
• Report Number: 0001038806-2021-01589
• Device Sequence Number: 11717900
• Product Code: DZE
• UDI-Device Identifier: 00844868007098
• UDI-Public: (01)00844868007098(17)240412(10)2019040275
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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: 04/12/2024
• Device Model Number: IOSS411
• Device Catalogue Number: IOSS411
• Device Lot Number: 2019040275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• 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: 08/03/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2019
• 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: 68 YR
• Patient Sex: Female