MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ WITH DCD¿ PARALLEL WALLED IMPLANT 6/5 X 13MM; DENTAL IMPLANT

Model Number	BNPS6513
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
Date of Event	08/29/2022
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 at tooth site #19 failed to integrate due to allergic was removed.Patient experienced significant pain stemming from implant site.Patient took multiple rounds of antibiotics with no relief.Patient found out from her orthopedic surgeon she is allergic to titanium and is having all titanium removed from her back and requested implant removal as well. surgical/medical intervention required for permanent damage: yes, patient took multiple rounds of antibiotics.Symptoms as a result of the event: pain, edema & inflammation.
Additional Manufacturer Narrative
One 3i t3 with dcd parallel walled implant 6/5 x 13mm (bnps6513) was returned for investigation.No damage identified or signs of malfunction that would contribute to the event.Measurements match drawing.The device could not be functionally tested for the reported failure (allergic reaction).Pre-existing condition noted on the per was unknown density.The reported devices have been placed on tooth #19.Placed on a previously xenografted site.X-ray & picture evaluation: x-ray and picture images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (2018101114).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, 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 (op0210) was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number (2018101114) for similar events and no other complaint was identified.Mar post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did not occur.However, the reported event could not be verified as the exact details of event were non-verifiable.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 3I T3¿ WITH DCD¿ PARALLEL WALLED IMPLANT 6/5 X 13MM
• 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: 16408848
• Report Number: 0001038806-2023-00339
• Device Sequence Number: 5898258
• Product Code: DZE
• UDI-Device Identifier: 00844868029441
• UDI-Public: (01)00844868029441(17)231113(10)2018101114
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 06/15/2023

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: Lay User/Patient
• Device Expiration Date: 11/13/2023
• Device Model Number: BNPS6513
• Device Catalogue Number: BNPS6513
• Device Lot Number: 2018101114
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2018
• 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 Age: 54 YR
• Patient Sex: Female
• Patient Weight: 86 KG