MAUDE Adverse Event Report: BIOTEX, INC. NS-320-185; BONE ANCHOR

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

During the procedure, the physician determined that a second ct scan was required prior to completion of the procedure.The pt was moved with the bot and fiber in-place back to the ct scanning area and during the move the bolt was broken with the threaded portion of the bolt remaining in the drilled hole.Dr.(b)(6), the physician took the pt back to the operating room and removed the threaded portion of the bolt.The procedure was completed successfully.

• Brand Name: NS-320-185
• Type of Device: BONE ANCHOR
• Manufacturer (Section D): BIOTEX, INC.; houston TX
• Manufacturer Contact: 8058 el rio st.; houston, TX 77054-4185 ; 7137410111
• MDR Report Key: 4095481
• MDR Text Key: 15122856
• Report Number: 3005726841-2014-00009
• Device Sequence Number: 1
• Product Code: HAO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2014
• 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