MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® IMPLANT 4 X 15MM; DENTAL IMPLANT.

Model Number	OSS415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).
Event or Problem Description
Doctor reports peri-implantatis around implant oss415.The implant was removed.Tooth site # 13.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).An osseotite® implant 4 x 15mm (oss415) was returned for investigation.Visual inspection of the returned product identified slight foreign material around the threads.Slight damage on threads possibly due to the removal process.Functional testing to recreate the reported events could not be performed due to the nature of the device and events.The returned device was measured and verified to match design history record (dhr) specifications the reported device tooth location is #25 and was used for approximately 2 years, 9 months pictures or x-ray images were not provided.A device history review was performed and no related nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Complainant reported patient develop peri-implantitis.The reported complaint of infection and bone loss could not be verified.A definitive root cause for this complaint could not be determined.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE® IMPLANT 4 X 15MM
• Common Device Name: DENTAL IMPLANT.
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9139749
• Report Number: 0001038806-2019-01135
• Device Sequence Number: 14237239
• Product Code: DZE
• UDI-Device Identifier: 00844868013204
• UDI-Public: (01)00844868013204(17)210630(10)2016061938(241)OSS415
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 06/30/2021
• Device Model Number: OSS415
• Device Catalogue Number: OSS415
• Device Lot Number: 2016061938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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
• Patient Age: 76 YR