MAUDE Adverse Event Report: BIOMET 3I 3I T3® WITH DCD® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 8.5MM; DENTAL IMPLANT

Model Number	BNSS485
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported that implants had to be removed due to allergic reaction.Procedure delayed 6 months.
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Additional device information unknown/not provided.Device manufacturer date unknown/not provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Product evaluation: the 4 implants were returned for investigation.Visual evaluation of the as returned implants identified signs of use (bone residue) around the external threads due to usage but no apparent signs of malfunction the device could not be functionally tested for the reported failure (allergic reaction).Pre-existing condition noted on the per was 'low bone density ¿ type iii'.The reported device had been placed on unknown tooth sites for approximately 1 year.X-ray or picture images were not provided.Review of appropriate documentation: document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev i - 2022/08/01.Information identified: contraindications, warnings, precautions, and potential adverse events.Per the applicable ifu, 'placement of dental implants may be precluded by both patient conditions that are contraindications for surgery as well as hypersensitivity to commercially pure titanium or titanium alloy'.Dhr review: dhr review for the lots (2019061964, 2019052378 & 2019041774) 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.Lots were inspected and passed all acceptance criteria by qa.Sterilization record review: sterilization record 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 numbers (2019061964, 2019052378 & 2019041774) for similar events (complaint category keywords: allergic reaction) and no other complaint was identified.Post market trending review: july post market trending was reviewed and there were no actionable events or corrective actions for the reported event or products.Therefore, based on the available information, device malfunction did not occur.The reported event could not be verified as the exact details of event and patient anatomical/physiological conditions were unknown/nonverifiable.

• Brand Name: 3I T3® WITH DCD® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 8.5MM
• 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: 14514318
• Report Number: 0001038806-2022-00776
• Device Sequence Number: 17515138
• Product Code: DZE
• UDI-Device Identifier: 00844868029083
• UDI-Public: (01)00844868029083(17)240524(10)2019041774
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

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: 05/24/2024
• Device Model Number: BNSS485
• Device Catalogue Number: BNSS485
• Device Lot Number: 2019041774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• 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: 05/02/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2019
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 67 KG