MAUDE Adverse Event Report: BIOMET 3I 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 13MM; DENTAL IMPLANT

Model Number	BOST513
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Age and date of birth unknown / not provided.Weight unknown / not provided.Expiration date and unique identifier (udi) number unknown / not provided.Email address unknown / not provided.Device manufacturer date unknown / not provided.
Event or Problem Description
It was reported that when the doctor was placing the third party restorative abutment, he could not get it to seat fully because of damage to the iimplant's internal hex connection.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The reported device was not returned for investigation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item and lot number along with the applicable device history record (dhr), instructions for use (ifu), and risk file.No pre-existing conditions were noted on the product experience report (per).The reported implant is located on tooth # 31 and has been in use for approximately 8 months.The customer did not provide any pictures or x-rays.Complainant reported that when the doctor was placing the third party restorative abutment, he could not get it to seat fully because of damage to the implant's internal hex connection.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 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: 15176327
• Report Number: 0001038806-2022-01200
• Device Sequence Number: 12017291
• Product Code: DZE
• UDI-Device Identifier: 00844868029670
• UDI-Public: (01)00844868029670(17)260111(10)2020120820
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2026
• Device Model Number: BOST513
• Device Catalogue Number: BOST513
• Device Lot Number: 2020120820
• Was Device Available for Evaluation?: No
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN THIRD PARTY ABUTMENT
• Patient Sex: Male