MAUDE Adverse Event Report: BIOMET 3I NANOTITE TM TAPERED CERTAIN IMPLANT 3.25 X 15MM; DENTAL IMPLANT

Model Number	NINT3215
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.
Event or Problem Description
It was reported that the interface w/zirconia final abutment with some movement.Implant at tooth site #7 was removed - planned new implant.Symptoms as a result of the event: none reported.
Additional Manufacturer Narrative
A nanotite tm tapered certain® implant 3.25 x 15mm (nint3215) was returned for investigation, see attached images in the complaint.Visual evaluation of the as returned product identified wear markings due to usage but no evidence of any damage.The returned device was measured with a caliper (cal1322 cal due: sep 25, 2020) and verified to match dhr specifications.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.No pre-existing conditions were noted on the per.The reported device was located on tooth # 7 and was used for approximately 7 years and 11 months.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1051586).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1051586) for similar event and no other complaint was identified.Based on the available information, device malfunction did not occur and the reported event was non-verifiable.The following sections have been updated: h3: changed "no" to "yes.".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NANOTITE TM TAPERED CERTAIN IMPLANT 3.25 X 15MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10200424
• Report Number: 0001038806-2020-00901
• Device Sequence Number: 19100942
• Product Code: DZE
• UDI-Device Identifier: 00844868011101
• UDI-Public: (01)00844868011101(17)160915(10)1051586(241)NINT3215
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/15/2016
• Device Model Number: NINT3215
• Device Catalogue Number: NINT3215
• Device Lot Number: 1051586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/12/2020
• 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: 70 YR