MAUDE Adverse Event Report: BIOMET 3I NANOTITE TM TAPERED CERTAIN® IMPLANT 4 X 10MM; DENTAL IMPLANT.

Model Number	NINT410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It is reported that the implant nint410 in site #19 was fractured and removed.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).A nanotite tm tapered certain® implant 4 x 10mm (item # nint410) was returned for investigation.Visual inspection of the returned product identified clearly evident fractures that have broken off portions of the implant, as well as a heavy coating of residue.The reported device was located on tooth # 19 and was used for approximately 4 years.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 hex fractured due to crown not stable.The reported complaint is confirmed through visual inspection of the returned product.A definitive root cause for this complaint could not be determined.The following sections have been updated: b4: date of this report.D4: expiration date, udi.G4: date received by manufacturer.G7: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes.' h4: device manufacture date.H6: evaluation codes.H10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: NANOTITE TM TAPERED CERTAIN® IMPLANT 4 X 10MM
• Common Device Name: DENTAL IMPLANT.
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9075057
• Report Number: 0001038806-2019-01072
• Device Sequence Number: 2452189
• Product Code: DZE
• UDI-Device Identifier: 00844868011125
• UDI-Public: (01)00844868011125(17)190924(10)2014091001(241)NINT410
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/01/2019
• Device Model Number: NINT410
• Device Catalogue Number: NINT410
• Device Lot Number: 2014091001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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