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

Model Number	BOES506
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.Last name unknown / not provided.
Event or Problem Description
It was reported that implant did not disengage from the mount when placing.No other implant could be placed because the implant bed was too big.Doctor placed graft on the implant site and once it is healed a new implant will be placed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The 3i t3® short external hex parallel walled implant, 5mm(d) x 6mm(l) (boes506) was not returned to palm beach gardens as it remains in spain.Since product has not been returned for investigation, visual/functional evaluation could not be performed.The investigation has been performed based on the available device information.A pre-existing condition noted on the per was low (type iii) bone density.The reported device was intended for use on tooth #46 (fdi) and was implanted/used for 1 day during the placement procedure.The customer did not provide pictures or x-ray images.Dhr review was completed for the subject lot number (2019080610).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, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2019080610) for similar events and no other complaint was identified.April post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or device (boes506).Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable as no pictures or objective evidence was provided for the reported device the following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes.'.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One 3i t3® short external hex parallel walled implant, 5mm(d) x 6mm(l) (boes506) and mount were returned for investigation.Visual evaluation of the as returned products identified mount engaged to implant and bone residue around the external threads of implant due to usage.Functional testing was performed to disengage the returned devices.Mount could not be disengaged from implant and required excessive force.Pre-existing condition noted on the per was low (type iii) bone density.The reported device was being placed on tooth #46 (fdi) when the incident occurred.X-ray or picture evaluation:the customer did not provide pictures or x-ray images.Dhr review was completed for the subject lot number (2019080610).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, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2019080610) for similar events and no other complaint was identified.May post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or devices.Therefore, based on the available information and functional testing, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 6MM(L)
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9877711
• Report Number: 0001038806-2020-00567
• Device Sequence Number: 18973050
• Product Code: DZE
• UDI-Device Identifier: 00844868033646
• UDI-Public: (01)00844868033646(17)240920(10)2019080610(241)BOES506
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K150571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2024
• Device Model Number: BOES506
• Device Catalogue Number: BOES506
• Device Lot Number: 2019080610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 06/09/2020; 07/30/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 06/17/2020; 08/13/2020
• 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
• Patient Age: 60 YR