MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 11.5MM; DENTAL IMPLANT

Model Number	IFNT511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant had to be removed due to the patient experiencing pain and discomfort after being restored.Implant was removed and replaced with another biomet implant.Tooth #30.
Additional Manufacturer Narrative
One full osseotite® tapered certain® implant 5 x 11.5mm (ifnt511) was returned for investigation.Visual evaluation of the as returned product identified signs of usage and some markings most likely caused during removal but no apparent malfunction was identified.Product matched print specification where measured and product was inspected.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was none.The reported device was located on tooth #30 (universal) and was used for approximately 2 years and 2 months.X-ray or picture image was not provided.Appropriate documentation was reviewed.Dhr review for the lot number (2017071427) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Complaint history review by lot number (2017071427) was performed for similar events and no other similar 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: g6: checked "follow-up".H3: changed "no" to "yes".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12128237
• Report Number: 0001038806-2021-01184
• Device Sequence Number: 4816488
• Product Code: DZE
• UDI-Device Identifier: 00844868005063
• UDI-Public: (01)00844868005063(17)220824(10)2017071427
• 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: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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: 08/24/2022
• Device Model Number: IFNT511
• Device Catalogue Number: IFNT511
• Device Lot Number: 2017071427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose