MAUDE Adverse Event Report: BIOMET 3I 3I T3® WITH DCD® TAPERED IMPLANT 4/3 X 13MM; DENTAL IMPLANT

Model Number	BNPT4313
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
The doctor reports that it was his error in orienting himself that caused perforation of the lingual table in immediate implant placement and it was necessary to remove the implant in the correct position, it did not have stability.The affected tooth position is #44.The procedure was not completed with another implant.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).During ongoing investigation it has been identified that the impant and lot reference do not match with the reported ones.The doctor could not provide correct reference and lot therefore this report is intended to update informaton to unknown.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One unknown biomet implant was returned for investigation.Visual evaluation of the as returned product identified signs of wear/use (bone/blood residue around the external/internal threads) but no apparent signs of malfunction.The implant could not be functionally tested for the reported event (bone fracture).Therefore, the reported event could not be recreated.Measurements were taken using cal1831 (due date: sep 2, 2022).Pre-existing conditions noted on the per were 'fenestration, oral hygiene and moderate bone density ¿ type ii'.The implant was being placed on tooth # 44 (fdi) when the incident occurred.Picture/x-ray evaluation: none provided.Review of appropriate documentation: document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev h ¿ july 2021.Information identified: contraindications, warnings, precautions, and potential adverse events.Per the applicable ifu, under the section 'precautions', it is stated that improper technique can lead to implant failure and loss of supporting bone.Dhr & complaint history review: dhr and complaint history review could not be performed since the lot/item number was not provided.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Post market trending review: march 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.The reported event could not be verified with the information provided.

• Brand Name: 3I T3® WITH DCD® TAPERED IMPLANT 4/3 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: 13505479
• Report Number: 0001038806-2022-00188
• Device Sequence Number: 17468696
• Product Code: DZE
• UDI-Device Identifier: 00844868028345
• UDI-Public: (01)00844868028345(17)260222(10)2021020276
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K122300
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2022

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: Health Professional
• Device Expiration Date: 02/22/2026
• Device Model Number: BNPT4313
• Device Catalogue Number: BNPT4313
• Device Lot Number: 2021020276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• 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: 01/20/2022
• Supplement Date Received by Manufacturer: 05/04/2022; 05/19/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 05/16/2022; 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2021
• 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: 63 YR
• Patient Sex: Male