MAUDE Adverse Event Report: BIOMET 3I CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H); DENTAL ABUTMENT

Model Number	IEHA453
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a defect in the product as it did not click.The procedure was completed using another device.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number: (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.G3: date received by the manufacturer.H1: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: evaluation codes.H10: additional narrative.One healing abutment was returned for investigation.Visual evaluation of the as returned product identified no sign of malfunction/damage.The product was returned outside of the original packaging which confirmed that the packaging was already opened by the customer.Functional testing was performed with an in-house implant.The product was able to seat onto the implant as intended (file: functional test).Patient pre-existing conditions, tooth location, placement duration and x-ray image were irrelevant to this investigation.Picture evaluation: picture image was not provided by the customer.Review of appropriate documentation: documents reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f ¿ october 2019.Information identified: warnings and precautions improper techniques can lead to device failure.Dhr review: dhr review for the lot: (1241335) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.The dhr was further reviewed to verify the product release information.No malfunction or nonconformance was identified.Complaint history review: complaint history review was performed for the reported lot number: (1241335) for similar events (complaint category keyword: functional: does not seat) and no other complaint was identified.Post market trending review: february post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did not occur.The reported event has been unconfirmed and the coob could not be confirmed.

• Brand Name: CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H)
• 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: 13042197
• Report Number: 0001038806-2021-02405
• Device Sequence Number: 1792060
• Product Code: NHA
• UDI-Device Identifier: 00844868004639
• UDI-Public: (01)00844868004639(17)251117(10)1241335
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: 11/17/2025
• Device Model Number: IEHA453
• Device Catalogue Number: IEHA453
• Device Lot Number: 1241335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• 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: 11/30/2021
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• 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 Sex: Unknown