MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ CERTAIN¿ IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Model Number	IOSS411
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Multiple mdr reports are filed for this event.See 0001038806 - 2023 -00005.
Event or Problem Description
The doctor reports that the dental implant failed due to an allergic reaction.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One osseotite certain implant 4 x 11.5mm (ioss411) and one osseotite tapered certain implant 3.25 x 13mm (int3213) was returned for investigation.Products had signs of use, there was bone debris on both implants.No damage identified or signs of malfunction that would contribute to the event.Measurements match drawing.The device could not be functionally tested for the reported failure (allergic reaction).Pre-existing condition noted on the per was low bone density ¿ type iv.The reported devices have been placed on teeth #unk.Dhr review was completed for the subject lot number (2020010320 and 2019030457).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.Sterilization record was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number (2020010320 and 2019030457) for similar events and no other complaint was identified.(complaint category keyword(s): medical: allergic reaction).Therefore, based on the available information, device malfunction did not occur.However, the reported event could not be verified as the exact details of event were non-verifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE¿ CERTAIN¿ IMPLANT 4 X 11.5MM
• 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: 16086189
• Report Number: 0001038806-2023-00004
• Device Sequence Number: 15129932
• Product Code: DZE
• UDI-Device Identifier: 00844868007098
• UDI-Public: (01)00844868007098(17)250121(10)2020010320
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: 01/21/2025
• Device Model Number: IOSS411
• Device Catalogue Number: IOSS411
• Device Lot Number: 2020010320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male