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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOHORIZONS, INC. BIOHORIZONS INTERNAL 3.5MM TITANIUM BASE ABUTMENT
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BIOHORIZONS, INC. BIOHORIZONS INTERNAL 3.5MM TITANIUM BASE ABUTMENT Back to Search Results
Model Number PYTB
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The returned package included a yellow anodized hex segment with no abutments.The complaint states that the hex belongs to a pytb.The hex did not show overtorqueing/twisting signs but may have fractured from excessive force applied to the prosthesis during use.Since the abutment and crown/restoration were not provided (physically nor photographically), it was not possible to determine the root cause of the failure.Information on patient habits and condition under which the prosthesis failed may have helped but were not available.
 
Event Description
Hex broke off abutment.
 
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Brand Name
BIOHORIZONS INTERNAL 3.5MM TITANIUM BASE ABUTMENT
Type of Device
INTERNAL 3.5MM TITANIUM BASE ABUTMENT
Manufacturer (Section D)
BIOHORIZONS, INC.
2300 riverchase center
birmingham 35244
Manufacturer (Section G)
BIOHORIZONS, INC.
2300 riverchase center
birmingham 35244
Manufacturer Contact
anissa smith
2300 riverchase center
birmingham 35244
2059867880
MDR Report Key7822101
MDR Text Key118537418
Report Number1060818-2018-00078
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 company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPYTB
Device Lot Number1504069
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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