MAUDE Adverse Event Report: BIOMET 3I 3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 6MM(D) X 5MM(L); DENTAL IMPLANT

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to report (b)(4).The following information is unknown at the time of this report: date of birth not provided.The device has been received for evaluation.The investigation has not yet begun.Once the investigation has been completed, a follow up medwatch will be submitted.
Event or Problem Description
It was reported that the impression coping would not disengage from the implant.Tooth location 29 was grafted and the patient was sent home to heal.The patient will return for implant placement.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections are being reported: b4: 06 aug 2019 b5: it was reported that the impression coping would not disengage from the implant.Tooth location 29 was grafted and the patient was sent home to heal.The patient will return for implant placement.D4: expiration date: 26 nov 2020.G4: 31 jul 2019.The reported device was returned for evaluation.Functional testing was performed for the returned product and it was determined the device failed functional testing as it took excessive force to remove the screw from the mount as well as excessive force to remove the mount from the implant after the screw was removed.The reported condition of an impression coping that would not disengage from the implant is confirmed.A device history record (dhr) review was completed for the reported device lot number.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.A complaint history review was performed for the reported device lot number for similar event and no other complaint was identified.A definitive root cause for the reported event could not be determined.The most likely causes for the reported event are customer error due to excessive torque and failure to follow recommended protocol.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the impression coping would not disengage from the implant.Tooth location 29 was grafted and the patient was sent home to heal.The patient will return for implant placement.

• Brand Name: 3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 6MM(D) X 5MM(L)
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8637917
• Report Number: 0001038806-2019-00451
• Device Sequence Number: 16666993
• Product Code: DZE
• UDI-Device Identifier: 00844868033653
• UDI-Public: (01)00844868033653(17)201126(10)2015111435(241)BOES605
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K150571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

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: 11/26/2020
• Device Model Number: N/A
• Device Catalogue Number: BOES605
• Device Lot Number: 2015111435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 WK