MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Model Number	IFNT411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	11/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient came back 3 days after implant placement with a lot of pain, implant was removed and the pain stop.Inflammation was also reported.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
One (1) full osseotite® tapered certain® implant 4 x 11.5mm (ifnt411) was returned for investigation.Visual evaluation of the as returned product identified no damage or signs of malfunction that would contribute to the event.Measurements match drawing.Cal3845 (due: sep 12, 2022) 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 moderate bone density (type ii).The reported device was located on tooth # 15 (fdi) and was used for approximately 7 days.The customer did not provide any pictures or x-rays.Review of appropriate documentation: document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev h ¿ (b)(6) 2021.Information identified: contraindications, warnings, precautions, and potential adverse events.Per the applicable ifu, improper techniques can cause device failure and persistent pain is listed as potential adverse event.Dhr review: dhr review was completed for the subject lot number (2020030696).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, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Sterilization record review: sterilization record (op# 0210) was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review: complaint history review was performed for the reported lot number (2020030696) for similar events (complaint category keywords: fracture: medical: pain) and no other complaint was identified.Post market trending review: feb post market trending was reviewed and there were no actionable events or corrective actions for the reported event (medical pain) or product (ifnt411).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did not occur and the reported event could not be verified as the exact details of event and patient anatomical conditions were unknown/non-verifiable.

• Brand Name: FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 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: 12917244
• Report Number: 0001038806-2021-02280
• Device Sequence Number: 5645503
• Product Code: DZE
• UDI-Device Identifier: 00844868005018
• UDI-Public: (01)00844868005018(17)250403(10)2020030696
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: 04/03/2025
• Device Model Number: IFNT411
• Device Catalogue Number: IFNT411
• Device Lot Number: 2020030696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/09/2021
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female