MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 15MM; DENTAL IMPLANT

Model Number	XIFNT415
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pseudoaneurysm (2605); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.B3: date of event unknown / not provided.E1: first name unknown / not provided.
Event or Problem Description
It was reported that implant collar fractured at site 10.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) xifnt415, (osseotite tapered certain implant 4 x 15mm) for evaluation.Visual evaluation was performed, a fracture has been identified on the implants collar.Dhr review was completed for the subject lot number 2015100076.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 2015100076 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : fracture : implant¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00053-haz, the most likely root cause determined from the investigation were material selection of implant inadequate (unable to withstand occlusal forces or long term loading) therefore, based on the available information, a device malfunction did occur.The fracture has been identified on the collar.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.

• Brand Name: OSSEOTITE TAPERED CERTAIN IMPLANT 4 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 ; 5617766700
• MDR Report Key: 16911097
• Report Number: 0001038806-2023-00899
• Device Sequence Number: 7451161
• Product Code: DZE
• UDI-Device Identifier: 00844868021988
• UDI-Public: (01)00844868021988(17)201007(10)2015100076
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

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: Other
• Device Expiration Date: 10/07/2020
• Device Model Number: XIFNT415
• Device Catalogue Number: XIFNT415
• Device Lot Number: 2015100076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2023
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic