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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS HEX ABUTMENTS

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BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS HEX ABUTMENTS Back to Search Results
Device Problems Use of Device Problem (1670); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
There was a total of 57 malfunction events associated with breakage or fracture of an abutment hex.21 of the 57 units were not returned for investigation.Since no product was returned for investigation, no conclusion can be drawn.A review of the device history record did not reveal any noted nonconformances.Hence, the conclusion was determined the device was manufactured to specifications.34 of the 57 units were returned for investigation for evaluation.22 of the 34 units were either damaged or misused by the end user.3 of the 34 units are pending investigation.4 of the 34 functioned as designed.Hence, no device impact connected to the malfunction.5 of the 34 units evaluated could not determine the cause of breakage.A device history record review did not reveal any nonconformances of reported and returned product.The evaluation of the 34 returned units determined 3 of them were not manufactured by biohorizons.The evaluation also noted the devices returned were broken or fractured.A fractured/broken abutment can occur due to the unit being over torqued during the restoration phase of the implant surgery completion procedure.Items involved: 3.0mm multi-unit abutment, 17-degree, 2.25mm collar; 3.0mm multi-unit abutment, straight 3mm collar; 3.5mm multi-unit abutment, 17-degree, 3mm collar; 3.5mm multi-unit abutment, 30-degree, 3mm collar; 3.5mm multi-unit abutment, 30-degree, 5mm collar; 3.5mm multi-unit abutment, straight 2mm collar; 4.5mm custom milled abutment; 4.5mm multi-unit abutment, 17-degree, 4mm collar; 5.7mm custom milled abutment.Biohorizons unknown prosthetic/component: internal 3.5mm custom cast abutment, hexed.Internal 4.5mm custom cast abutment, hexed.
 
Event Description
This report summarizes 57 malfunction events.A review of the events involved abutment hexes breaking or fracturing.These reports were received from various sources.No patient consequences were noted for the 57 events.No information regarding the patient demographics were provided.
 
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Brand Name
BIOHORIZONS HEX ABUTMENTS
Type of Device
HEX ABUTMENTS
Manufacturer (Section D)
BIOHORIZONS IMPLANT SYSTEMS
2300 riverchase center
birmingham AL 35244
Manufacturer (Section G)
BIOHORIZONS IMPLANT SYSTEMS
2300 riverchase center
birmingham AL 35244
Manufacturer Contact
anissa smith
2300 riverchase center
birmingham, AL 35244
MDR Report Key11752154
MDR Text Key250469615
Report Number1060818-2021-03777
Device Sequence Number1
Product Code NHA
Combination Product (y/n)N
Number of Events Reported57
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 04/30/2021
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? No
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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