MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® 2 IMPLANT 3.25 X 11.5MM; DENTAL IMPLANT

Model Number	XFOSM311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	06/30/2014
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 peri-implantitis.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Osseointegrated dental implants are an important tool in prosthetic dentistry and provide edentulous patients with alternative replacements for teeth.Although most implants are extremely successful, with survival rates of up to 98% for implants placed in controlled clinical settings, implants can fail.Problems associated with this minor defect rate are infection, bone loss, and/or peri-implantitis, which are likely attributed external factors including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.These events are previously investigated failures which are currently trended on a monthly basis.Current implant design and manufacturing risk documentation assess infection, bone loss, and peri-implantitis as potential failures with adequate controls in place.Monthly trending to date has not identified any statistical triggers suggesting potential design or manufacturing related issues.Previously completed investigations for these events have not identified any signals indicating potential non-conformances impacting the manufacturing and sterilization processes.Furthermore, the probability of a manufacturing or design defect that might lead to infection and result in bone loss occurring and escaping the available detections has been assessed and found remote and almost nonexistent.With no signals indicating a systemic quality issue, no escalation to capa is required.The following sections have been updated: b4: date of this report.B5: describe event or problem.G4: date received by manufacturer.G7: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer.H6: event problem and evaluation codes.H10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE® 2 IMPLANT 3.25 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9961875
• Report Number: 0001038806-2020-00690
• Device Sequence Number: 2804410
• Product Code: DZE
• UDI-Device Identifier: 00844868024033
• UDI-Public: (01)00844868024033(17)160923(10)2011090197(241)XFOSM311
• 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: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2016
• Device Model Number: XFOSM311
• Device Catalogue Number: XFOSM311
• Device Lot Number: 2011090197
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 06/05/2020
• 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: 69 YR