MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 X 13MM; DENTAL IMPLANT

Model Number	INT3213
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor reports that the dental implant located in position #21 failed because during the positioning of the implant inside the site, an incorrect coupling between the driver and the implant was highlighted, therefore it was not possible to position it.The dental procedure was completed with another implant and the patient did not suffer any type of negative impact on his health as a consequence of the event.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One osseotite® tapered certain® implant 3.25 x 13mm (int3213) was returned for investigation.Visual evaluation of the as returned product identified no apparent signs of malfunction.Functional testing was performed with an in-house driver.Implant and driver were able to engage and disengage as normal.Pre-existing condition noted on the per was low bone density ¿ type iii.The reported implant was being placed on tooth #21 (fdi).Device history record (dhr) review for the lot (2021111000) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimvie.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2021111000) for similar events (complaint category keywords: damaged drive feature) and no other complaint was identified.Therefore, based on the available information and functional testing, device malfunction did not occur for the implant and could not be verified for the driver.Additionally, the reported event could not be verified.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 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: 15351166
• Report Number: 0001038806-2022-01366
• Device Sequence Number: 17598667
• Product Code: DZE
• UDI-Device Identifier: 00844868006619
• UDI-Public: (01)00844868006619(17)261129(10)2021111000
• 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: Other Health Care 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INT3213
• Device Catalogue Number: INT3213
• Device Lot Number: 2021111000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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
• Patient Sex: Female