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	Unspecified Infection (1930)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).
Event or Problem Description
Doctor reports that patient presented with peri-implantitis around implant iosm313.The implant was removed.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections are being reported: device evaluated by manufacturer was updated.Method code was updated to 3331 and 4109.Results code was updated to 213.Conclusions code was updated to 4310.The reported device was received for evaluation.The reported condition of bone loss and infection was not confirmed.Visual inspection of the as returned product identified minor signs of wear and bone residue around the external threads due to usage.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.A device history record (dhr) review was completed for the reported device lot.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance, which could have caused or contributed to the reported event was noted as part of the dhr.All sterilization activities were conducted with no issues or nonconformities identified per sterilization record.A complaint history review was completed for the reported device lot for similar event and no other complaint was identified.A definitive root cause for the reported event could not be determined.
Event or Problem Description
No additional or corrected information to 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
• MDR Report Key: 9207628
• Report Number: 0001038806-2019-01205
• Device Sequence Number: 305288
• Product Code: DZE
• UDI-Device Identifier: 00844868007043
• UDI-Public: (01)00844868007043(17)180910(10)2013071603(241)IOSM313
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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: 09/10/2018
• Device Model Number: IOSM313
• Device Catalogue Number: IOSM313
• Device Lot Number: 2013071603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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