MAUDE Adverse Event Report: BIOMET 3I 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 5MM(L; DENTAL IMPLANT

Model Number	BOES505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Paresthesia (4421); Swelling/ Edema (4577)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth location 30 was removed due to bone fracture.Patient broke jaw in an accident.Symptoms caused by the event: pain, edema, inflammation and paresthesia.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Investigation summary the complaint reported that the implants at tooth locations 45 and 46 were removed due to bone fracture.One 3i t3 short external hex parallel walled implant, (boes505) and one 3i t3 short external hex parallel walled implant (boes605) were returned for evaluation (see images attached).Visual/physical evaluation of the as returned products identified signs of use but no apparent signs of malfunction.Functional testing could not be performed due to that nature of the devices and event.This investigation addresses the implant boes505.Dhr review was completed for the subject lot number 2018091488.No deviations or non-conformance's, 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 2018091488 for similar events and no other complaint was identified.Review completed utilizing keywords: 'dental: medical: bone fracture.' the customer did not submit images for the reported event.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu (p-iis086gi), rev j - 7/31/2022.Information identified: contraindications.Per the applicable ifu, 'biomet 3i dental implants should not be placed in patients where the remaining jawbone is too diminished to provide adequate implant stability'.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was accident - per complaint description, the patient¿s jaw was broken in an accident.Therefore, based on the available information, device malfunction has not occurred.Additionally, the reported event could not be verified as the exact details of event were unknown/unverifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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
It was reported that the implants at tooth locations 45 and 46 were removed due to bone fracture.Patient broke jaw in an accident.Symptoms caused by the event: pain, edema, inflammation and paresthesia.

• Brand Name: 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 5MM(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 ; 5617766700
• MDR Report Key: 16743389
• Report Number: 0001038806-2023-00728
• Device Sequence Number: 5298160
• Product Code: DZE
• UDI-Device Identifier: 00844868033639
• UDI-Public: (01)00844868033639(17)231003(10)2018091488
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150571
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/21/2023

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: Health Professional
• Device Expiration Date: 10/03/2023
• Device Model Number: BOES505
• Device Catalogue Number: BOES505
• Device Lot Number: 2018091488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2018
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic