MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED IMPLANT 3.25 X 11.5MM; DENTAL IMPLANT

Model Number	NT3211
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported that the mount was stuck on implant at the time of placement.Clinician tried to remove the mount and was not able, had prepare the implant site at tooth location 21 to put another implant of 4.1 because that's all that was available in stock.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One osseotite® tapered implant 3.25 x 11.5mm (nt3211) and mount were returned for investigation (image 1 to 4).Visual evaluation of the as returned product identified some signs of usage due to stuck mount.The head of the mount identified damaged as well.Functional testing was performed.The mount was stuck in the implant and could not be disengaged.Patient had the bone density of type iv (low density).The implant had been placed on tooth #34 (universal) but could not finish procedure since the mount was unable to disengage and had to put another implant of 4.1 because that¿s all customer had in stock.X-ray or picture image was not provided.Appropriate documentation was reviewed.Dhr review for the lot number (2019060190) 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.Complaint history review by lot number (2019060190) was performed for similar events and no complaint about nonconforming products was identified.Based on the available information, device malfunction did occur and the reported event was confirmed.The following sections have been updated: b4: date of this report g4: date received by manufacturer g7: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h6: entered evaluation codes h10: added manufacturer narrative.

• Brand Name: OSSEOTITE TAPERED IMPLANT 3.25 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10754862
• Report Number: 0001038806-2020-01686
• Device Sequence Number: 3318532
• Product Code: DZE
• UDI-Device Identifier: 00844868011972
• UDI-Public: (01)00844868011972(17)240614(10)2019060190(241)NT3211
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2024
• Device Model Number: NT3211
• Device Catalogue Number: NT3211
• Device Lot Number: 2019060190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 02/02/2021
• 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: 48 YR