MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ WITH DCD¿ NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 10MM; DENTAL IMPLANT

Catalog Number	BNST510
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sinus Perforation (2277); Swelling/ Edema (4577)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reports that the dental implant located in position number #16 failed due to a sinus perforation.The procedure was not concluded with the placement of another implant, and the patient did not suffer any negative impact on his health.Antibiotic therapy was initiated.The doctor also reports that the site presented edema, abscess, and infection.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).D4: additional device information unknown / not provided.H4: device manufacturer date unknown / not provided.H6: event problem codes ¿ patient code: 1690 abscess.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) bnst510, (3i t3l with dcdl non-platform switched tapered implant 5 x 10mm) for evaluation.Visual evaluation was performed, the implant had signs of use.Bone debris on the internal threads.No damage to the implant was identified.No signs of malfunction that would contribute to the event.Device history record (dhr) review was completed for the subject lot number 2022061266.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 2022061266 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : non integration : perforated sinus.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was missing or confusing instructions for use or inadequate treatment planning.Therefore, based on the available information, a device malfunction did not occur.No damage to the implant was identified.The reported event was non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3¿ WITH DCD¿ NON-PLATFORM SWITCHED TAPERED IMPLANT 5 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 17830865
• Report Number: 0001038806-2023-01868
• Device Sequence Number: 17569141
• Product Code: DZE
• UDI-Device Identifier: 00844868029298
• UDI-Public: (01)00844868029298(17)270714(10)2022061266
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• 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): 03/07/2024

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 Catalogue Number: BNST510
• Device Lot Number: 2022061266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic