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)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).
Event or Problem Description
It is reported that the abutment was loose in the implant.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).
Event or Problem Description
It is reported that the abutment was loose in the implant.
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
The reported device was returned and the reported event could not be verified as the exact details of device usage and the patient¿s anatomical conditions were unknown.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 device that could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or corrective actions for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Device history record (dhr) review was completed for the subject lot number.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, 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.A lot specific complaint history review is not conducted for psp complaints as patient specific products have a unique one time use lot number.The reported event is related to the functional performance of the device but cannot be recreated without return of the screw.A definitive root cause could not be determined.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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• 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: 13523264
• Report Number: 0001038806-2022-00202
• Device Sequence Number: 17261568
• Product Code: NHA
• UDI-Device Identifier: 00844868031406
• UDI-Public: (01)00844868031406(10)8392116-1
• 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): 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: ILDAT4
• Device Catalogue Number: ILDAT4
• Device Lot Number: 8392116-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female