MAUDE Adverse Event Report: ZIMMER DENTAL TSV® BELLATEK® FLEX ABUTMENT 4.5MM (D) 12MM (H) HEXED

Model Number	TF4121
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight: patient weight not provided.
Event or Problem Description
It was reported that the abutment screw became loose.The doctor retightened it and the patient was sent home.
Additional Manufacturer Narrative
One (1) tsv® bellatek® flex abutment 4.5mm (d) 12mm (h) hexed (tf4121) was not returned for investigation as they remain in use.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number along with the applicable instructions for use (ifu) and risk management file.The complaint addressed the 1st event for screw loosening.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Per: no pre-existing conditions were noted on the complaint.Bone density type was unknown.The reported device was located on tooth site #30 (universal).Picture/x-rays: pictures or x-ray images were not provided.Review of appropriate documentation: instructions for use for zimmer dental implant systems 4894 rev 6 - 08/19.Tsv bellatek® express and bellatek® flex abutment and the tsv titanium asc screw products.¿ p-texpflex rev.B ¿ 04/21.Information identified: single use.Single use: do not reuse tsv bellatek express and bellatek flex abutments and the retaining screw.Reuse of a single use device that has come in contact with blood, bone, tissue, body fluids or other contaminants may lead to patient or user injury.Dhr review: dhr review was completed for the subject lot number (2020030504 ¿ tf4121).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.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: a lot specific complaint history review was conducted for the subject lot number (2020030504-tf4121) and revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product for similar events (complaint category keyword: loosening).Post market trend review: may post market trending was reviewed and there were no negative trends or corrective actions for the reported event (functional loosening) and device (tf4121).Malf/event: based on the available information, device malfunction could not be verified and the reported event was non-verifiable.Sections updated: b4: date of this report.G3: date investigation was received.G6: type of report and follow up number.H2: follow up type.H3: device evaluated.H6: adverse event problem codes.H10: manufacturer's narrative.
Event or Problem Description
There is no update to the original complaint description provided.

• Brand Name: TSV® BELLATEK® FLEX ABUTMENT 4.5MM (D) 12MM (H) HEXED
• Common Device Name: ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13482692
• Report Number: 0002023141-2022-00265
• Device Sequence Number: 1714053
• Product Code: NHA
• UDI-Device Identifier: 00844868043973
• UDI-Public: (01)00844868043973(17)991231(10)2020030504
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K192522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/22/2022

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 Model Number: TF4121
• Device Catalogue Number: TF4121
• Device Lot Number: 2020030504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2020
• 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: 40 YR
• Patient Sex: Male