MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE IMPLANT 3.75 X 13MM; DENTAL IMPLANT

Model Number	OSS313
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant was removed due to fracture.Site presented bone loss.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).A osseotite® implant 3.75 x 13mm (oss313) was returned for investigation.Visual inspection of the as returned product identified the implant to be fractured.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.No pre-existing conditions were noted on the per.The reported device was located on tooth 16 and was used for approximately 15 years.Pictures or x-ray images were not provided.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu (p-iis086gi) rev g ¿ october 2019 information identified: 'warnings' 'precautions' 'potential adverse events'.Dhr review was completed for the subject lot number (254781).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (254781) for similar event and no other complaint was identified.December post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction could not be verified for bone loss however, did occur and the reported event was confirmed for fracture.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE IMPLANT 3.75 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10792669
• Report Number: 0001038806-2020-01747
• Device Sequence Number: 1138457
• Product Code: DZE
• UDI-Device Identifier: 00844868013129
• UDI-Public: (01)00844868013129(17)091012(10)254781(241)OSS313
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2021

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 Expiration Date: 10/01/2009
• Device Model Number: OSS313
• Device Catalogue Number: OSS313
• Device Lot Number: 254781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 02/05/2021; 02/23/2021
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 02/19/2021; 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 64