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

Model Number	NIOSS413
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the patient came to medical center due to crown loosening and mobility of implant.When checking the implant, doctor noticed that the internal implant hex was damaged and the screw was loose.The implant in dental site 4 was removed.
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.G4: date received by manufacturer.G7: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer.H6: event problem and evaluation codes.H10: additional narrative.One nanotite certain® implant 4 x 13mm (nioss413) was returned for investigation.Visual evaluation of the as returned product identified signs of wear and bone residue around the external threads due to usage.Additionally, the device drive feature was damaged.Functional testing was performed with an applicable device.The devices could not assemble properly due to damaged drive feature on the implant.Pre-existing condition noted on the per was moderate bone density type ii.The devices had been placed on tooth #15 (fdi) for approximately 10 years.X-ray or picture images were not provided.Device history record (dhr) review for the lot (788745) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the lot (788745) for similar events and no other complaint was identified.Therefore, based on the available information, implant malfunction did occur and damaged drive feature was confirmed.

• Brand Name: NANOTITE TM CERTAIN® IMPLANT 4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9816959
• Report Number: 0001038806-2020-00484
• Device Sequence Number: 3068869
• Product Code: DZE
• UDI-Device Identifier: 00844868011354
• UDI-Public: (01)00844868011354(17)130205(10)788745(241)NIOSS413
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K051461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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: Health Professional
• Device Expiration Date: 02/05/2013
• Device Model Number: NIOSS413
• Device Catalogue Number: NIOSS413
• Device Lot Number: 788745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 05/20/2020
• 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