MAUDE Adverse Event Report: BIOMET 3I DO NOT USE-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	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported the implant in tooth location 19 fractured in the neck and was removed.
Additional Manufacturer Narrative
Zimmer biomet complaint (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).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.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: adverse event problem h10: additional narrative one nanotite tm certain® prevail® implant 4/5/4 x 13mm (niios4513), removal tool and crown were returned for investigation.Visual evaluation of the as returned product identified that the implant was fractured at the neck and the removal tool was still engaged with it.Additionally, there was bone residue around the external threads which were severely damaged.There were no allegations against the removal tool and the crown.Therefore, the investigation was performed only on the implant and the associated event.The device history record (dhr) was not available electronically for the subject lot number (742291) thus could not be further reviewed at the time of the investigation.A notification to manufacturing has been sent and requested to pull the dhr for review.The pce will be reopened and updated if there is any indication of nonconformance, or any possible manufacturing issue related to the reported event.Complaint history review was completed for the subject lot number (742291) and no similar complaints/events were identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.Additionally, an unreported malfunction was identified as the implant could not disengage from the removal tool.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: DO NOT USE-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: 10948622
• Report Number: 0001038806-2020-01976
• Device Sequence Number: 16303964
• Product Code: DZE
• UDI-Device Identifier: 00844868010791
• UDI-Public: (01)00844868010791(17)121017(10)742291(241)NIIOS4513
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K051461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 03/31/2021

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: Health Professional
• Device Expiration Date: 10/17/2012
• Device Model Number: NIIOS4513
• Device Catalogue Number: NIIOS4513
• Device Lot Number: 742291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 03/15/2021; 03/31/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 03/23/2021; 03/31/2021
• 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
• Patient Age: 61 YR