MAUDE Adverse Event Report: BIOMET 3I CERTAIN® EP® HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H)

Catalog Number IMHA34

Device Problem Failure to Advance (2524)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Patient age and weight not provided/ unknown.Event date not provided/unknown.Device lot number not provided/unknown.

Event Description

It was reported that the abutment had trouble seating onto the implant in the patient's mouth.Customer requested to change abutments.

Manufacturer Narrative

One healing abutment was returned for investigation.Visual evaluation of the as returned product identified minor nicks and signs of wear due to usage around the post and the drive feature.A device history review was performed and no related nonconformance¿s were noted.A complaint history search was performed using our complaint handling system and there were no additional related complaints against this lot.Appropriate documentation was reviewed.Functional testing was performed using an in-house implant.The device could not seat on the implant.The alleged device malfunction was confirmed.A root cause cannot be determined.The following sections have been updated: h3: changed "no" to "yes".

Event Description

No further event information available at the time of this report.

• Brand Name: CERTAIN® EP® HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H)
• Type of Device: HEALING ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9707699
• MDR Text Key: 180554526
• Report Number: 0001038806-2020-00336
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Device Catalogue Number: IMHA34
• Device Lot Number: 1064883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1