MAUDE Adverse Event Report: BA-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 04/19/2014

Event Type  malfunction  

Event Description

Distributor reported that upon removal of the bone anchor following a procedure, it was noticed that a section of the bone anchor threads appeared to be missing.The surgeon did not return the pt to the operating room and closed without exploration.

• Brand Name: BA-320-185
• Type of Device: BONE ANCHOR
• Manufacturer Contact: ashok gowda ; 8058 el rio; houston, TX 77054 ; 7137410111
• MDR Report Key: 3904637
• MDR Text Key: 15808010
• Report Number: 3005726841-2014-00004
• 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: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• 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: 05/23/2013
• 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