MAUDE Adverse Event Report: BIOMET 3I 3I T3® TAPERED IMPLANT 5/4 X 10MM; DENTAL IMPLANT

Model Number BOPT5410

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2022

Event Type  malfunction  

Event Description

Doctor reported that when trying to place the implant doctor noticed that the inner packaging was damaged (pulled over), implant was not placed.Another implant was placed instead.Tooth site 36.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age at time of the event unknown / not provided.Gender unknown / not provided.Weight unknown / not provided.Additional device information unknown / not provided.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem d4: additional device information 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 an 3i t3â® tapered implant 5/4 x 10mm (bopt5410) was returned for investigation.Visual inspection of the as returned product identified worn markings.No damage identified to the product or package.Device history record (dhr) review was completed for the subject lot number (2021041314).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2021041314) for similar event and no other complaint was identified.Based on the available information, device malfunction did not occur and the reported event was unconfirmed.

Event Description

No further event information is available at the time of this report.

• Brand Name: 3I T3® TAPERED IMPLANT 5/4 X 10MM
• Type of Device: 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: 14186012
• MDR Text Key: 289862120
• Report Number: 0001038806-2022-00568
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 00844868028505
• UDI-Public: (01)00844868028505(17)260510(10)2021041314
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K122300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BOPT5410
• Device Catalogue Number: BOPT5410
• Device Lot Number: 2021041314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1