MAUDE Adverse Event Report: BIOMET 3I CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H)

Model Number	IEHA564
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the healing abutments would not seat in the patient's mouth.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual inspection of the returned product identified worn markings due to usage, however no malfunction.Functional testing was performed for the returned products with an in-house stock implant and seats as intended.No malfunction.No pre-existing conditions were noted on the product experience report (per).The length of the device usage is unknown.Pictures or x-ray images were not provided.A device history record (dhr)review was performed and no related deviations or non-conformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.Complainant reported that the healing abutments would not seat in the patient's mouth.The reported complaint could not be confirmed.A definitive root cause for this complaint could not be determined.The following sections have been updated: d9: device available for evaluation change ¿no' to 'yes'.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: evaluation codes.H10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H)
• Common Device Name: HEALING 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: 13279267
• Report Number: 0001038806-2022-00066
• Device Sequence Number: 4934373
• Product Code: NHA
• UDI-Device Identifier: 00844868004806
• UDI-Public: (01)00844868004806(17)250108(10)1235182
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• 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): 06/30/2022

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: Health Professional
• Device Expiration Date: 01/08/2025
• Device Model Number: IEHA564
• Device Catalogue Number: IEHA564
• Device Lot Number: 1235182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/22/2021
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female