MAUDE Adverse Event Report: BIOHORIZONS, INC. BIOHORIZON INTERNAL ONE-PIECE HEX DRIVER; INTERNAL HEX DRIVER

Model Number 135-351

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

No conclusion can be drawn due to no product was returned for investigation.Physician did not report any problems with the patient after x-ray.

Event Description

Patient swallowed a hex driver during the removal of a bridge.

• Brand Name: BIOHORIZON INTERNAL ONE-PIECE HEX DRIVER
• Type of Device: INTERNAL HEX DRIVER
• 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: 8257372
• MDR Text Key: 133464066
• Report Number: 1060818-2018-00091
• 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: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 135-351
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1