MAUDE Adverse Event Report: BIOMET 3I CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM; DENTAL ABUTMENT

Model Number	ILDAT4
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number cmp (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the abutment on an unknown tooth site became loose in the patient's mouth.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were updated: 10, 4109, 4110, 4111.H6: investigation findings code was updated: 213.H6: investigation conclusion code was updated: 4315.H10: narrative/data was updated.One certain bellatek titanium abutment 4.1mm, ildat4 and one certain gold-tite hexed screw was returned for investigation.Visual inspection via naked eye and camera magnification revealed a crown attached to the abutment.Signs of cement/calculus identified at abutment/crown junction.The product was returned, and the reported event (loosening) could not be verified, as the exact details of device usage and the patient¿s anatomical conditions were unknown.Also, no x-rays were provided for the reported events.Based on the evaluation the device malfunction could not be verified.Additionally, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported devices that could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or corrective actions for the reported events or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the products were within specifications and conforming when they left zimvie.A lot number specific complaint history review is not conducted for psp complaints.Patient specific products have a unique one-time use lot number.Therefore, a lot number specific history search for this complaint is not performed.A complaint history review by item number was conducted for the iunihg dating back to 12 months from notification date, for similar events and revealed that there are no existing non-conformance's/capa/hhe/d/ie/product holds for the reported product.The reported event could not be recreated due to the nature of the dental device and event (loosening) and the complaint is related to the functional performance of the device.A definitive root cause could not be identified.However, based on the investigation and risk review, the most likely cause for the reported event is inadequate treatment planning, misunderstood or overlooked instructions for use, screw not torqued to specification or improper technique.No further investigation or immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.
Event or Problem Description
No additional event information was received at the time of this report.

• Brand Name: CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM
• Common Device Name: DENTAL ABUTMENT
• 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: 15914454
• Report Number: 0001038806-2022-01850
• Device Sequence Number: 17823334
• Product Code: DZE
• UDI-Device Identifier: 00844868031406
• UDI-Public: (01)00844868031406(10)8752524-1
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K052648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: ILDAT4
• Device Catalogue Number: ILDAT4
• Device Lot Number: 8752524-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown