MAUDE Adverse Event Report: BIOMET 3I CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)

Catalog Number	IEHA454
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient weight not provided/unknown.Device brand name unknown.Device product code unknown.Device catalog and lot number not provided/unknown.Device not returned.
Event or Problem Description
It was reported that the healing abutment could not seat onto the implant.Tooth site 4.
Additional Manufacturer Narrative
One healing abutment was returned attached to its associated implant.Visual evaluation of the as returned abutment identified moderate signs of wear about the abutment body and retaining screw.No device lot number was provided so a device history record review and a complaint history review could not be performed.Appropriate documentation was reviewed.Functional testing determined that the healing abutment and implant mated and seated as intended.No device malfunction was found.The alleged device malfunction was unconfirmed.A root cause cannot be determined.The following sections have been updated: b4: date of this report.D1: device brand name.D2: device product code.D4: device catalog number.D10: device availability.G4: date received by manufacturer.G7: checked "follow-up." h2: checked follow-up type.H3: changed "no" to "yes." h6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)
• Common Device Name: HEALING ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10174192
• Report Number: 0001038806-2020-00870
• Device Sequence Number: 2609650
• Product Code: NHA
• Combination Product (Y/N): N
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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 Catalogue Number: IEHA454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR