MAUDE Adverse Event Report: BIOMET 3I 3I T3® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 10MM; DENTAL IMPLANT

Model Number	BOSS410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Inflammation (1932)
Date of Event	05/17/2020
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 at tooth site # 16 lost integration due to infection and sinus perforation and was removed.Symptoms as a result of the event: abscess and inflammation.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narrative.One 3i t3® non-platform switched parallel walled implant 4 x 10mm (boss410) and abutment were returned for investigation.Visual evaluation of the as returned implant identified no apparent signs of malfunction.The complaint alleged loss of integration due to infection and sinus perforation.Infection is a well-documented event that is developed in some patients following implantation of the devices.The device could not be functionally tested for the reported failures/events (perforated sinus + infection).However, measurements were taken on aug 04, 2021using a caliper.Following dimensional analysis and comparison to drawings, the device was determined to be within design specifications.Device history record (dhr) review for the lot (2019051762) 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.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2019051762) for similar events (complaint category keywords: functional: loss of integration: perforated sinus & infection) and no other complaint was identified.Therefore, based on the available information and dimensional analysis, device malfunction did not occur.However, the reported events could not be verified as the exact details of event and patient anatomical conditions were unknown/nonverifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 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: 12244268
• Report Number: 0001038806-2021-01391
• Device Sequence Number: 5127985
• Product Code: DZE
• UDI-Device Identifier: 00844868028819
• UDI-Public: (01)00844868028819(17)240607(10)2019051762
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 06/07/2024
• Device Model Number: BOSS410
• Device Catalogue Number: BOSS410
• Device Lot Number: 2019051762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• 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: 06/10/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2019
• 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: 51 YR
• Patient Sex: Female