MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® IMPLANT 3.75 X 10MM; DENTAL IMPLANT

Model Number	FOS310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that implant fractured one year after loading.Implant was removed.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One full osseotite® implant 3.75 x 10mm (fos310) was returned for investigation.Visual inspection of the as returned product identified a complete fracture on the threads of the implant as well as dried blood and bone around the device.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Pre-existing conditions noted on the product experience report (per) were smoker and moderate ¿ low bone density (type ii-iii).The reported device was located on tooth # 36 (fdi) and was used for 1 year 9 months.The customer provided x-rays (attached) which also show the fracture in the last x-ray.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 implant fractured.The product was returned.The reported fracture was confirmed via visual inspection.A definitive root cause for this complaint could not be determined.The following sections have been updated: b4: date of this report.G7: type of report, follow-up number.H2: follow up type.H6: evaluation codes.H10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: FULL OSSEOTITE® IMPLANT 3.75 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9443172
• Report Number: 0001038806-2019-01555
• Device Sequence Number: 16650654
• Product Code: DZE
• UDI-Device Identifier: 00844868003489
• UDI-Public: (01)00844868003489(17)211107(10)2016101961(241)FOS310
• 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: 2018
• 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): 02/12/2020

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: Lay User/Patient
• Device Expiration Date: 11/07/2021
• Device Model Number: FOS310
• Device Catalogue Number: FOS310
• Device Lot Number: 2016101961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 02/12/2020
• 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: 49 YR