MAUDE Adverse Event Report: BIOMET 3I NANOTITE TM CERTAIN PREVAIL IMPLANT 4/5/4 X 13MM; DENTAL IMPLANT

Model Number	NIIOS4513
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported that implant fractured at the neck portion, it was removed and a bnst10 was placed on the site.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A nanotite tm certain® prevail® implant 4/5/4 x 13mm (niios4513) although the manufacturer (zb eu authorized representative) has received the product, the manufacturing/investigation site has not received/evaluated the actual device due to covid protocols and delays in shipment.Therefore the product has not been physically inspected and the investigation has been performed based on the available information.Device history record (dhr) review was completed for the subject lot number (810982).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 (810982) for similar event and no other complaint was identified.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.
Event or Problem Description
No further event information is available at the time of this report.
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 following sections have been updated: b4: date of this report b5: describe event or problem d4: unique identifier (udi) number changed to unknown g3: date received by manufacturer g7: type of report, follow-up number h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative a nanotite tm certain® prevail® implant 4/5/4 x 13mm (niios4513) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage and a fracture on the collar.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.No pre-existing conditions were noted on the per.The reported device location is unknown and was used for approximately 10 years and 11 months.Device history record (dhr) review was completed for the subject lot number (810982).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 (810982) for similar event and no other complaint was identified.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.

• Brand Name: NANOTITE TM CERTAIN PREVAIL IMPLANT 4/5/4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10436036
• Report Number: 0001038806-2020-01203
• Device Sequence Number: 3105419
• Product Code: DZE
• UDI-Device Identifier: 00844868010791
• UDI-Public: (01)00844868010791(17)130418(10)810982(241)NIIOS4513
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K051461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2021

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: 04/18/2013
• Device Model Number: NIIOS4513
• Device Catalogue Number: NIIOS4513
• Device Lot Number: 810982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 11/25/2020; 02/09/2021
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 11/30/2020; 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention