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

Model Number 73715

Device Problems Break (1069); Detachment Of Device Component (1104); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

The surgeon tapped the pedicle.When he backed out/removed the instrument, he heard a pop and noticed a part had broke off.

Manufacturer Narrative

Mdr being submitted as a result of a retrospective complaint review.An evaluation is not possible at this time.The identifying lot number has not been provided nor has the instrument been returned.Multiple attempts to obtain the item in question have been unsuccessful.

• Brand Name: TAO, CANNULATED, 4.5MM (STAINLESS STEEL)
• Type of Device: HWX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: vernon trimble ; 5818 el camino real; carlsbad, CA 92008 ; 7604946648
• MDR Report Key: 4903985
• MDR Text Key: 6833903
• Report Number: 2027467-2015-00129
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• 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: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• 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: 10/30/2014
• 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