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

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.

• 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 Key: 7807314
• MDR Text Key: 118111280
• Report Number: 1060818-2018-00054
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PGCAH
• Device Lot Number: 1506535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Number: 1