MAUDE Adverse Event Report: BIOHORIZONS, INC. BIOHORIZONS INTERNAL 3.5MM CUSTOM CAST HEXED ABUTMENT; INTERNAL HEXED CUSTOM CAST ABUTMENT

Model Number PYCAH

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Therefore, no physical evaluation could be performed to confirm complaint.

Event Description

Hex broke off of the abutment.

• Brand Name: BIOHORIZONS INTERNAL 3.5MM CUSTOM CAST HEXED ABUTMENT
• Type of Device: INTERNAL HEXED CUSTOM CAST 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
• MDR Report Key: 7439601
• MDR Text Key: 106013780
• Report Number: 1060818-2018-00023
• Device Sequence Number: 1
• Product Code: NDP
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: PYCAH
• Device Catalogue Number: PYCAH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1