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

Model Number	FOS411
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number cmp (b)(4).Weight unknown / not provided.Last name unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported tha the implant was removed due to 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.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes.' a full osseotite® implant 4 x 11.5mm (fos411) was returned for investigation.Visual inspection of the as returned product identified excessive foreign blood and debris along with damage and fracture at the top of implant.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 # 46 and usage of length is approximately 13 years and 3 months.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'.Also, according to the ifu, patient factors like presence of occlusal abnormalities or parafunctional habits (e.G.Severe bruxism, clenching, overloading or gnawing) may cause screw loosening, restoration fracture, and/or implant failure.Dhr review: dhr review was completed for the subject lot number (648874).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 (648874) 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 did occur and the reported event was confirmed.

• Brand Name: FULL OSSEOTITE IMPLANT 4 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10926387
• Report Number: 0001038806-2020-01938
• Device Sequence Number: 13829937
• Product Code: DZE
• UDI-Device Identifier: 00844868003618
• UDI-Public: (01)00844868003618(17)120308(10)648874(241)FOS411
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2012
• Device Model Number: FOS411
• Device Catalogue Number: FOS411
• Device Lot Number: 648874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 02/25/2021; 03/22/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 03/16/2021; 03/31/2021
• 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: 72 YR
• Patient Weight: 86