MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 13MM; DENTAL IMPLANT

Model Number	INT413
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant had to be removed due to the patient having an allergic reaction with pain at the site.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One (1) osseotiteâ® tapered certainâ® implant 4 x 13mm (int413) was returned for investigation.Visual evaluation of the as returned product identified no apparent signs of malfunction.Zimvie is not responsible for any damage caused by the clinician's removal of the device.The device could not be functionally tested for the reported event/failure (allergic reaction).However, through measurements, dimensional analysis, and comparison to drawings, the device was determined to be within design specifications when it left zimvie.Pre-existing conditions were not noted on the per.The reported device was at an unknown tooth location for approximately 1 year.Device history record (dhr) review was completed for the subject lot number 2019111519.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: allergic reaction.Therefore, based on the available information and dimensional analysis, device malfunction did not occur.Additionally, the reported event could not be verified since it is a medical condition, and no x-ray or pictorial evidence was available (patient anatomical condition and details of event were unknown).
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 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: 15298225
• Report Number: 0001038806-2022-01321
• Device Sequence Number: 5825879
• Product Code: DZE
• UDI-Device Identifier: 00844868006664
• UDI-Public: (01)00844868006664(17)241128(10)2019111519
• 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: 2021
• 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): 01/10/2023

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: 11/28/2024
• Device Model Number: INT413
• Device Catalogue Number: INT413
• Device Lot Number: 2019111519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2019
• 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: 44 YR
• Patient Sex: Female