MAUDE Adverse Event Report: BIOMET 3I NANOTITE TM TAPERED CERTAIN PREVAIL IMPLANT 5/4 X 11.5MM; DENTAL IMPLANT

Model Number	NIITP5411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that customer stated the implant was showing through the tissue and too far to the buccal side.Tooth location 29.Doctor made new treatment plan for patient.Patient will return to have a full arch placed.
Additional Manufacturer Narrative
The product was returned for investigation.The reported event is non-verifiable.A device history review was performed and no related nonconformance¿s were noted.A complaint history search was performed using our complaint handling system and there were no additional related complaints against this lot.Appropriate documentation was reviewed.Based on the evaluation, the device malfunctions did not occur.There is not enough evidence to form a conclusion on the reported event.Therefore, the complaint is non-verifiable.A root cause cannot be determined.The following sections have been updated: g7: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Supplemental medwatch created as udi was originally incorrectly provided under mfr #0001038806- 2020-00555.
Event or Problem Description
There is no update to the original description provided.

• Brand Name: NANOTITE TM TAPERED CERTAIN PREVAIL IMPLANT 5/4 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9865196
• Report Number: 0001038806-2020-00555
• Device Sequence Number: 11482689
• Product Code: DZE
• UDI-Device Identifier: 00844868010982
• UDI-Public: (01)00844868010982(17)170110(10)2011121416(241)NIITP5411
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2021

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: 09/23/2019
• Device Model Number: NIITP5411
• Device Catalogue Number: NIITP5411
• Device Lot Number: 2011121416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 05/07/2020; 01/27/2021
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/12/2020; 01/28/2021
• 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: 40 YR
• Patient Weight: 70