MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE¿ TAPERED IMPLANT 3.25 X 10MM; DENTAL IMPLANT

Catalog Number	FNT3210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
Doctor reported loss of integration a month after implant's placement due to necrosis at tooth site 44.Patient has been rescheduled for new implant placement.Patient is smoker.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) full osseotite tapered implant 3.25 x 10mm, (fnt3210) for evaluation.Visual/physical evaluation identified bone debris on external threads and other signs of use (wear) but no apparent signs of malfunction.Functional test could not be performed for the reported failure (necrosis).Dhr review was completed for the subject lot number 2018112224.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2018112224 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿medical: other.¿ therefore, based on the available information, device malfunction did not occur.Additionally, the reported event could not be verified as the exact details of event were unknown/unverifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: FULL OSSEOTITE¿ TAPERED IMPLANT 3.25 X 10MM
• 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: 17006983
• Report Number: 0001038806-2023-01021
• Device Sequence Number: 15038742
• Product Code: DZE
• UDI-Device Identifier: 00844868003274
• UDI-Public: (01)00844868003274(17)231211(10)2018112224
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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: Other
• Device Expiration Date: 12/10/2023
• Device Catalogue Number: FNT3210
• Device Lot Number: 2018112224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic