MAUDE Adverse Event Report: BIOMET 3I CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H)

Model Number	IEHA464
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Patient's weight was not provided.Event date is unknown.Title of reporter was not provided.
Event or Problem Description
It was reported that the patient presented with a loose crown and abutment.Healing abutment was replaced with a new one.No patient impact reported.Tooth #19.
Additional Manufacturer Narrative
One certain® bellatek® encode® healing abutment 4.1mm(d) x 6mm(p) x 4mm(h) (ieha464) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage but no damage was identified.Functional testing could not be performed due to the nature of the device and event.No pre-existing conditions were noted on the per.The reported device was located on tooth # 19 and was used for approximately 1 year and 4 months.X-ray & picture evaluation: x-ray or picture images were not provided.Per the applicable ifu, under section "precautions", it is stated that improper technique could cause screw loosening.Also, according to the ifu, patient factors like presence of occlusal abnormalities or parafunctional habits (e.G.Severe bruxism, clenching, overloading, or gnawing) may cause screw loosening.Dhr review: dhr review was completed for the subject lot number (1216774).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: complaint history review was performed for the reported lot number (1216774) for similar event and no other complaint was identified.Post market trend review: january post market trending was reviewed and there were no actionable events or corrective actions for the reported event (functional: loosening) or product (ieha464).Therefore, based on the available information, device malfunction and the reported events could not be verified as the exact details of event were non-verifiable.Sections updated: b4: date of this report g3: date pce/ investigation results were received.G6: type of report and follow up number h2: follow up type h3: device evaluated h6: adverse event product codes h10: manufacturer's narrative.
Event or Problem Description
There is no update to the original complaint description provided.

• Brand Name: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H)
• Common Device Name: ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11111758
• Report Number: 0001038806-2021-00004
• Device Sequence Number: 19731905
• Product Code: NHA
• UDI-Device Identifier: 00844868004684
• UDI-Public: (01)00844868004684(17)230627(10)1216774(241)IEHA464
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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 Expiration Date: 06/27/2023
• Device Model Number: IEHA464
• Device Catalogue Number: IEHA464
• Device Lot Number: 1216774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR