MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® CERTAIN® IMPLANT 3.25 X 13MM; DENTAL IMPLANT

Model Number	IOSM313
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implants was removed due to medical bone loss.
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Patient identifier: (b)(6).Weight unknown / not provided.Expiration date and unique identifier (udi) number unknown / not provided.Device manufacturer date unknown / not provided.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).A device history record review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were two related complaints for this product lot.Complainant reported that the implant was removed due to bone loss at the implant site.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.Bone loss: a summary investigation has been completed for bone loss 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 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.The following sections have been updated: d9: device available for evaluation change ¿no' to 'yes'.H3: device evaluated by manufacturer: change ¿no' to 'yes'.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE® CERTAIN® IMPLANT 3.25 X 13MM
• 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: 14527073
• Report Number: 0001038806-2022-00815
• Device Sequence Number: 5799195
• Product Code: DZE
• UDI-Device Identifier: 00844868007043
• UDI-Public: (01)00844868007043(17)211216(10)2016110196
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2022

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: 12/16/2021
• Device Model Number: IOSM313
• Device Catalogue Number: IOSM313
• Device Lot Number: 2016110196
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 10/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2016
• 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: 65 YR
• Patient Sex: Female