MAUDE Adverse Event Report: BIOMET 3I T3 PRO TAPERED IMPLANT 5/4MM (D) X 13MM (L); DENTAL IMPLANT

Catalog Number	T3PT5413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.H3 other text : summary investigation.
Event or Problem Description
It was reported tooth was removed using elevators and forceps with complication.Decorticated.The osteotomy was prepared using osteotomes.No scout film was obtained.No surgical guide was used.A zb tapered 5/4x13 mm implant was placed.Torqued 40 ncm.Co/ca/xe regeneross bone was used to graft the peri-implant defect.An encode 465 healing abutment was placed.On (b)(6) 2023 patient returned for surgical release site #4 and instructed to continue care with dr.On (b)(6) patient called our office stating dentist discovered an infection at site #4 during routine cleaning.On (b)(6), patient were evaluated in out office and there was a 6mm probing depth on the dl with a parulis on the facial.In nov a full thickness flap was reflected.Implant was removed using a trephine burr and forceps, the osteotomy was debrided of all soft tissue down to the healthy bone.Site was smooth, irrigated, decorticated.Co/ca/xe regeneross bone mixed with prf exudate was used to graft the extraction site.Aprf membrane was placed over the graft.

• Brand Name: T3 PRO TAPERED IMPLANT 5/4MM (D) X 13MM (L)
• 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 ; 5619713230
• MDR Report Key: 18377547
• Report Number: 0001038806-2023-02486
• Device Sequence Number: 20727928
• Product Code: DZE
• UDI-Device Identifier: 00844868046783
• UDI-Public: (01)00844868046783(17)270801(10)2022070585
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K213672
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2023

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: T3PT5413
• Device Lot Number: 2022070585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic