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

Model Number	IOSS411
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown/not provided.Email address was not provided.Product not returned.
Event or Problem Description
It was reported that the implant at tooth site 12 fracture and remains implanted due to the patients.Doctor will check the implant on yearly basis.
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).The osseotite® certain® implant 4 x 11.5mm (ioss411) was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.No pre-existing conditions were noted on the per.The reported product was located on tooth # 24 (fdi) and used for approximately 3 years prior to the notification date.The reported event could not be recreated due to the nature of the dental device and event (fracture).Device history record (dhr) review was completed for the subject lot number 2015110607.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 (2015110607) for similar event and no other complaint was identified.Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.
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.

• 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
• MDR Report Key: 10769281
• Report Number: 0001038806-2020-01704
• Device Sequence Number: 1901738
• Product Code: DZE
• UDI-Device Identifier: 00844868007098
• UDI-Public: (01)00844868007098(17)201117(10)2015110607(241)IOSS411
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2021

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: 11/17/2020
• Device Model Number: IOSS411
• Device Catalogue Number: IOSS411
• Device Lot Number: 2015110607
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 01/04/2021; 02/10/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 01/19/2021; 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1