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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOHORIZONS, INC. BIOHORIZONS MULTI-UNIT ABUTMENT 30 - DEGREE; 30-DEGREE MULTI-UNIT ABUTMENT
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BIOHORIZONS, INC. BIOHORIZONS MULTI-UNIT ABUTMENT 30 - DEGREE; 30-DEGREE MULTI-UNIT ABUTMENT Back to Search Results
Model Number PYMU303
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The returned unit pymu303 (multi unit abutment) included unit pxmuas ( multi-unit abutment screw).The multi-unti abutment returned did not show any damage but the multi-unit abutment screw was stuck within the abutment due to biologic debris and plastic deformation.The evaluation revealed excessive force was applied during use.The multi-unit abutment are designed with internal threads and the multi-unit abutment screw was designed to screw into the unit.The screw appear to have been pushed into the abutment unit during placement instead of being screwed.The evaluation concluded excessive torque was applied.Therefore, the screw engagement allegation was a use error.
 
Event Description
The multi-unit abutment would not engage an abutment screw.
 
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Brand Name
BIOHORIZONS MULTI-UNIT ABUTMENT 30 - DEGREE
Type of Device
30-DEGREE MULTI-UNIT ABUTMENT
Manufacturer (Section D)
BIOHORIZONS, INC.
2300 riverchase center
birmingham AL 35244
Manufacturer (Section G)
BIOHORIZONS, INC.
2300 riverchase center
birmingham AL 35244
Manufacturer Contact
anissa smith
2300 riverchase center
birmingham, AL 35244
2059867888
MDR Report Key7390554
MDR Text Key104274180
Report Number1060818-2018-00012
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Model NumberPYMU303
Device Catalogue NumberPYMU303
Device Lot Number1704042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2018
Was the Report Sent to FDA? No
Date Manufacturer Received02/13/2018
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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