MAUDE Adverse Event Report: ALPHATEC SPINE INC TAP, CANNULATED, 4.5MM (STAINLESS STEEL); HWX

Model Number 73715

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/11/2014

Event Type  Injury  

Event Description

During a minimally invasive surgery, the tip of an illico cannulated tap fractured and became detached from the instrument.The detached section remains entrapped within the female patients l3 pedicle.

Manufacturer Narrative

No evaluation possible.The suspect device has been discarded by the user facility.The identifying lot number has not been provided.

• Brand Name: TAP, CANNULATED, 4.5MM (STAINLESS STEEL)
• Type of Device: HWX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: david mcgrath ; 5818 el camino real; carlsbad, CA 92008 ; 7604946936
• MDR Report Key: 4251445
• MDR Text Key: 5045853
• Report Number: 2027467-2014-00040
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 73715
• Device Catalogue Number: 73715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2014
• 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
• Patient Outcome(s): Other