MAUDE Adverse Event Report: ALPHATEC SPINE INC CANNULATED EXTENDED TAB POLYAXIAL REDUCTION SCREW, 5.5MM X 45MM (TITANIUM); THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 15025-055-045

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

No evaluation possible at this time.The implants has not been removed from the patient nor has the identifying lot number(s) been provided.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.The kodiak spinal fixation system is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications.The kodiak spinal fixation system consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and cross connectors that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.The screws, hooks, connectors, and cross connectors are manufactured from surgical grade titanium alloy (ti-6al-4v eli).The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (cp ti grade 4, ti-6al-4v eli, and co-28cr-6mo).

Event Description

When snapping off the tabs, two of the tabs did not break off in the correct spot.The threaded portion of the tab stayed on the screw tulip.Additional surgery is not required at this time.

• Brand Name: CANNULATED EXTENDED TAB POLYAXIAL REDUCTION SCREW, 5.5MM X 45MM (TITANIUM)
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: richard younger ; 5818 el camino real; carlsbad, CA 92008 ; 7604946842
• MDR Report Key: 8285247
• MDR Text Key: 134910657
• Report Number: 2027467-2018-00090
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190376117720
• UDI-Public: (01)00190376117720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15025-055-045
• Device Catalogue Number: 15025-055-045
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2018
• Initial Date FDA Received: 01/29/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 60 YR