MAUDE Adverse Event Report: BIOMET 3I 3I T3 WITH DCD PARALLEL WALLED IMPLANT 6/5 X 10MM; DENTAL IMPLANT

Model Number	BNPS6510
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported that the implant at tooth site #19 was removed due to damaged threads.Implant was placed (b)(6) 2019 and was removed.Restoring dentist stripped and damaged internal threads so it was not restorable.Per indicated: surgical/medical intervention required for permanent damage: yes, removed implant and grafted site on (b)(6) 2020.Additional appointment required: yes, replaced on (b)(6) 2020.Symptoms as a result of the event: none reported.
Additional Manufacturer Narrative
One 3i t3® with dcd® parallel walled implant (bnps6510) was returned for investigation.Visual evaluation of the as returned implant identified that the drive feature was severely damaged (hex and collar).Additionally, there was bone residue around the external threads that were also damaged (possibly during removal).Functional testing could not be performed since the implant was severely damaged and the tool unreturned.Pre-existing conditions, tooth location, x-ray and implantation duration are irrelevant to this investigation.Picture images were not provided.Appropriate documentation was reviewed.Dhr review for the lot had revealed no deviations nor non-conformances which could have caused or contributed to the reported event after implantation of the device.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 reported lot and no similar event or complaint was found.Based on the available information, implant malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 3I T3 WITH DCD PARALLEL WALLED IMPLANT 6/5 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10943453
• Report Number: 0001038806-2020-01963
• Device Sequence Number: 13613378
• Product Code: DZE
• UDI-Device Identifier: 00844868029427
• UDI-Public: (01)00844868029427(17)220824(10)2017071091(241)BNPS6510
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/24/2022
• Device Model Number: BNPS6510
• Device Catalogue Number: BNPS6510
• Device Lot Number: 2017071091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 02/22/2021
• 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: 81 YR