MAUDE Adverse Event Report: BIOMET 3I 3I T3 PARALLEL WALLED IMPLANT 4/3 X 15MM; DENTAL IMPLANT

Catalog Number	BOPS4315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported infection and lower jaw fracture at tooth site 44.Doctor also reported massive osteoporosis.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D4: unique identifier (udi) number not available.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4) zimvie received one (1) bops4315, (3i t3 parallel walled implant 4/3 x 15mm) for evaluation.Visual evaluation was performed, the implant had signs of use with blood and bone debris on the internal and external threads.No damage identified or signs of malfunction that would contribute to the event.Measurements match drawing.Dhr review was completed for the subject lot number 2022091167.No deviations or non-conformances, 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 2022091167 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : medical : bone fracture and dental : medical : infection.The customer did submit an image for the reported event.The image was an x-ray of the patient¿s mouth.Image can be found in the attachments tab.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was external factors (i.E.Patient condition).Therefore, based on the available information, a device malfunction did not occur.No damage to the implant was identified.The reported event was non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were 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
Doctor reported infection and lower jaw fracture at tooth site 44.Doctor also reported massive osteoporosis.Upon follow up made by email on 16 apr 2024 doctor confirmed that bone fracture happened due to a bike accident.Bone density is normal.After the accident the cyst and the necrotic bones were removed, roughened and bleeding allowed, none bone substitute material was used.Patient does not wish any other surgeries, a bridge will be made.

• Brand Name: 3I T3 PARALLEL WALLED IMPLANT 4/3 X 15MM
• 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: 18463665
• Report Number: 0001038806-2024-02591
• Device Sequence Number: 11541944
• Product Code: DZE
• UDI-Device Identifier: 00844868029755
• UDI-Public: (01)00844868029755(17)271007(10)2022091167
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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: BOPS4315
• Device Lot Number: 2022091167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic