MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE 2 IMPLANT 3.75 X 11.5MM; DENTAL IMPLANT

Model Number	XFOS311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported implant removed due to fracture.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The osseotite® 2 implant 3.75 x 11.5mm (xfos311) was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.No pre-existing conditions were noted on the per.The reported product was located on tooth # 46 (fdi) and used for approximately 3 years.The reported event could not be recreated due to the nature of the dental device and event (fracture).The customer has not provided additional pictures or x-ray images of the product.Review of appropriate documentation: documents reviewed: p-iis086gi rev.G 10/2019; potential adverse events; page 1 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 was completed for the subject lot number 2013100903.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.April post market trending was reviewed and there were no actionable events or corrective actions for the reported event (implant fracture) or product (xfos311).Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.The following sections have been updated: 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.
Additional Manufacturer Narrative
Zimmerbiomet complaint number: (b)(4).One osseotite® 2 implant 3.75 x 11.5mm (xfos311) was returned for inspection.Visual evaluation of the returned device notes that the implant is fractured at the collar and shows signs of trephine removal.No pre-existing conditions were noted on the per.The reported product was located on tooth 46 (fdi) and used for approximately 3 years.The reported event could not be recreated due to the nature of the dental device and event (fracture).Dhr review was completed for the subject lot number 2013100903.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 (2013100903) for similar event and 2 other complaint were identified under (b)(4).June post market trending was reviewed and there were no actionable events or corrective actions for the reported event (implant fracture) or product (xfos311).Therefore, based on the available information, device malfunction has occurred and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE 2 IMPLANT 3.75 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9961903
• Report Number: 0001038806-2020-00691
• Device Sequence Number: 16845149
• Product Code: DZE
• UDI-Device Identifier: 00844868023791
• UDI-Public: (01)00844868023791(17)181029(10)2013100903(241)XFOS311
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2020

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: 10/29/2018
• Device Model Number: XFOS311
• Device Catalogue Number: XFOS311
• Device Lot Number: 2013100903
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 06/10/2020; 08/11/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 06/17/2020; 09/03/2020
• 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: 52 YR