MAUDE Adverse Event Report: BIOHORIZONS, INC. BIOHORIZONS ABUTMENT

Model Number UNKNOWN

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 abutment.

• Brand Name: BIOHORIZONS ABUTMENT
• Type of Device: 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: 7439604
• MDR Text Key: 106016661
• Report Number: 1060818-2018-00026
• 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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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