MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ IMPLANT 3.75 X 13MM; DENTAL IMPLANT

Model Number	OSS313
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the dental implant located in unknown position failed because it was fractured in the neck, the doctor indicates in the per that the procedure was not yet concluded with the placement of other implant.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Two osseotite implant 3.75 x 10mm (oss310), and one osseotite implant 3.75 x 13mm (oss313) were returned for investigation.Visual evaluation of the as returned implants identified signs of use, apparent bone attached to external threads.The implants were fractured at the collar region.Functional testing could not be performed since the products were fractured.Pre-existing condition noted on the per was low bone density ¿ type iii.The reported device had been placed on tooth #unk for approximately 2 years.X-ray or picture image was not provided.Appropriate documentation was reviewed.Dhr review for the lot number (2020021720, 2019011588, and 2019031346) had revealed no deviations nor non-conformance's which could have caused or contributed to the reported event.Products was conforming at the time it left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2020021720, 2019011588, and 2019031346) for similar events and one other complaint was identified (b)(4).Investigation has yet to be completed and results are not available at this time.Mar 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.

• Brand Name: OSSEOTITE¿ IMPLANT 3.75 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: 16383650
• Report Number: 0001038806-2023-00307
• Device Sequence Number: 5138155
• Product Code: DZE
• UDI-Device Identifier: 00844868013129
• UDI-Public: (01)00844868013129(17)240402(10)2019031346
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 05/30/2023

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: 04/02/2024
• Device Model Number: OSS313
• Device Catalogue Number: OSS313
• Device Lot Number: 2019031346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• 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: 02/10/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG