MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE CERTAIN IMPLANT 4 X 8.5MM; DENTAL IMPLANT

Model Number	IOSS485
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Weight unknown / not provided.Unique identifier (udi) number unknown / not provided.
Event or Problem Description
It was reported that the implant at tooth site 4 fractured at the neck portion, only the top portion was returned by the doctor.Bottom part was aspirated by the machine after removal.
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® certain® implant 4 x 10mm (ioss410) and one osseotite® certain® implant 4 x 8.5mm (ioss485) were returned for investigation.Visual evaluation of the as returned products identified signs of wear and fracturing across the threads.Only the top fractured portions were returned.Device history record (dhr) review was completed for the subject lot number 2015080419 and 2015101473.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 was 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 (2015080419) and (2015101473) for similar event and no other complaint was identified.Therefore, based on the available information, device malfunction has occurred and the reported event was confirmed.

• Brand Name: OSSEOTITE CERTAIN IMPLANT 4 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11320834
• Report Number: 0001038806-2021-00254
• Device Sequence Number: 19864717
• Product Code: DZE
• UDI-Device Identifier: 00844868007142
• UDI-Public: (01)00844868007142(17)201029(10)2015101473(241)IOSS485
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/29/2020
• Device Model Number: IOSS485
• Device Catalogue Number: IOSS485
• Device Lot Number: 2015101473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR