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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOHORIZONS, INC. BIOHORIZONS INTERNAL 4.5MM CUSTOM CAST ABUTMENT, HEXED; 4.5 CUSTOM CAST ABUTMENT

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BIOHORIZONS, INC. BIOHORIZONS INTERNAL 4.5MM CUSTOM CAST ABUTMENT, HEXED; 4.5 CUSTOM CAST ABUTMENT Back to Search Results
Model Number PGCAH
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Device not returned for evaluation.Therefore, no conclusion may be drawn.
 
Event Description
Hex broke off abutment.
 
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Brand Name
BIOHORIZONS INTERNAL 4.5MM CUSTOM CAST ABUTMENT, HEXED
Type of Device
4.5 CUSTOM CAST 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 Key7807314
MDR Text Key118111280
Report Number1060818-2018-00054
Device Sequence Number1
Product Code NHA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Dentist
Type of Report Initial
Report Date 08/17/2018
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 Model NumberPGCAH
Device Lot Number1506535
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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