MAUDE Adverse Event Report: BIOMET 3I CERTAIN® BELLATEK® TITANIUM ABUTMENT 5.0MM; DENTAL ABUTMENT

Model Number	ILDAT5
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Abutment when antically placed was fine.Since receiving abutment ¿ they¿ve had to replace the screw a few times.Now the abutment rocks & is not seating at all properly.Patient called and reported it is already loose again.Scheduled to tighten it and discuss next steps.Sales rep reported the abutment does seat, but it will not stay seated.It loosens up every few weeks despite using a new screw or not.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One certain® bellatek® titanium abutment 5.0mm, ildat5 was not returned for investigation.Visual inspection of the product could not be performed and the investigation was based on the risk management files and appropriate ifu.Functional testing of the ildat4 could not be performed since the product was not returned.This is the last in a series of abutment screw loosening, re-tightening of screw and replacement of screw.The complaint is reported as the abutment not seating.Therefore, this investigation will be of the abutment but with the history of the screw loosening taken into consideration.No pre-existing conditions were noted on the per.The device was intended for tooth position #3 (universal) and was used for approximately 1 year 3 months when the incident occurred.Pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review was performed for the ildat5 with subject lot number (8509805-1).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.A lot specific complaint history review is not conducted for psp complaints.Patient specific products have a unique one time use lot number.Therefore, a lot specific history search for this complaint is not performed.Based on the available information, device malfunction of the ildat5 could not be verified and the reported event was non-verifiable.The following sections have been updated: h3: changed "yes" to "no".Product not returned.

• Brand Name: CERTAIN® BELLATEK® TITANIUM ABUTMENT 5.0MM
• 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: 13384800
• Report Number: 0001038806-2022-00109
• Device Sequence Number: 4998830
• Product Code: NHA
• UDI-Device Identifier: 00844868031413
• UDI-Public: (01)00844868031413(10)8509805-1
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: ILDAT5
• Device Catalogue Number: ILDAT5
• Device Lot Number: 8509805-1
• 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: 12/14/2021
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose