MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED IMPLANT 5 X 8.5MM; DENTAL IMPLANT

Model Number	NT585
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier: not provided.Patient weight: not provided.
Event or Problem Description
It was reported that the mount was difficult to separate from the implant.Patient will not have to return to place a new implant.
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; d4: expiration date and udi; g3: date received by the manufacturer; h1: type of report, follow-up number; h2: follow up type; h3: device evaluated by manufacturer: change ¿no' to 'yes'; h4: device manufacture date; h6: evaluation codes; h10: additional narrative.One implant was returned for investigation.Visual evaluation of the as returned product identified minor signs of use.Functional testing to recreate the reported event; verified the devices do not disengage.Malfunction.A pre-existing condition noted on the per was low bone density (type iii).The reported implant was located on an unknown tooth site (universal) and was used, placed and removed on the same day.The customer did not provide any pictures or x-rays.Review of appropriate documentation: document reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f - october 2019 & biomet 3i dental implant ifu p-iis086gi rev.J 2022/08.Information identified: contraindications, warnings, precautions and potential adverse events.Per the applicable ifu, under the section 'precautions', it is stated that improper technique may lead to device failure.Dhr review: dhr review was completed for the subject lot number (2019111817).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: complaint history review was performed for the reported lot number (2019111817) for similar events and no other complaint was identified.Review completed utilizing keywords: 'does not disengage/release' post market trending review: november post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or product (nt585).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, and functional testing device malfunction did occur and the reported event was confirmed.

• Brand Name: OSSEOTITE® TAPERED IMPLANT 5 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15349271
• Report Number: 0001038806-2022-01363
• Device Sequence Number: 5227347
• Product Code: DZE
• UDI-Device Identifier: 00844868012108
• UDI-Public: (01)00844868012108(17)241213(10)2019111817
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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: Lay User/Patient
• Device Expiration Date: 12/13/2024
• Device Model Number: NT585
• Device Catalogue Number: NT585
• Device Lot Number: 2019111817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male