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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I UNKNOWN 3I BELLATEK ABUTMENT; DENTAL ABUTMENT
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BIOMET 3I UNKNOWN 3I BELLATEK ABUTMENT; DENTAL ABUTMENT Back to Search Results
Device Problem Unintended Movement (3026)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Zimmer biomet (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Brand name unknown / not provided.Catalog and lot number unknown / not provided.Fax number unknown / not provided.Pma/510(k) number not available.Device manufacture date not available.
 
Event Description
It was reported that the crown loosened in the patients mouth and they believe there may be a malfunction or defect with the abutment.
 
Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Based on additional information received, there was no injury, significant delay and no alleged failure of the abutment.Therefore, this event does not meet the definition of a reportable event.As a result, the prior submissions for mfr- 0001038806-2021-00234 submitted on february 10, 2021 is no longer considered a reportable event by the manufacturer and a report will be submitted for the associated screw for this event.No further reports will be submitted for this device.
 
Event Description
Additional information received: customer stated that they were unaware of any defect with the abutment.They only want to replace the screw at the moment.
 
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Brand Name
UNKNOWN 3I BELLATEK ABUTMENT
Type of Device
DENTAL ABUTMENT
Manufacturer (Section D)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
MDR Report Key11309226
MDR Text Key231211486
Report Number0001038806-2021-00234
Device Sequence Number1
Product Code NHA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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