MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 13MM; DENTAL IMPLANT

Model Number	INT513
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported that internal prosthetic connection is damaged.The doctor also reported edema and poor bone quality.Patient has been rescheduled for new implant placement.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.H4: device manufacture date not available.One implant was returned for investigation.Visual evaluation of the as returned product identified damage to the drive feature.Zimvie is not responsible for any damage caused by the clinician's removal of the device.Functional testing was not performed due to the nature of the device and event.Pre-existing condition noted on the per was high bone density (type i).The reported device was at tooth location 26 (universal) but was placed and removed the same day.The customer did not provide x-rays or images.Document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev j - 2022/08.Information identified: warnings precautions potential adverse events.Per the applicable ifu, it is stated that improper techniques can cause bone loss, patient injury, pain, and implant failure.Dhr review was completed for the subject lot number 2021051048.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.Review completed utilizing keywords: damaged drive feature.November post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® 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: 15348516
• Report Number: 0001038806-2022-01359
• Device Sequence Number: 12045553
• Product Code: DZE
• UDI-Device Identifier: 00844868006718
• UDI-Public: (01)00844868006718(17)260603(10)2021051048
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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 Expiration Date: 06/03/2026
• Device Model Number: INT513
• Device Catalogue Number: INT513
• Device Lot Number: 2021051048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male