MAUDE Adverse Event Report: ALPHATEC SPINE INC AXIAL ROD CONNECTOR, 5.5 X 5.5 X 30 MM (TI-6AL-4V ELI); PEDICLE SCREW SYSTEM

Model Number 47008-55-030

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 08/17/2017

Event Type  Injury  

Manufacturer Narrative

A review of the device history records found no manufacturing, processing or design related irregularities.The implant was found to be properly manufactured and released in accordance with the device master record.The axial rod connector is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.

Event Description

Patient bent over and heard a pop.It was discovered that the axial rod connector had become disengaged from the rod.Revision surgery was conducted on (b)(6) 2017 to remove the rod connector from the construct.The arsenal fixation system was originally implanted on (b)(6) 2017.

Manufacturer Narrative

An evaluation of the returned axial connector found wear patterns on both the set screw and body which are consistent with an implant that has experienced high impact loads.Similar wear patterns have been replicated in bench top testing by imparting high impact forces on the rod within a set screw-rod-pedicle screw construct.The high impact forces push the rod through the interface and results in the deep gouging on the distal surface of the set screw.The position of the connector while implanted, was at a location as an interbody device.When an interbody device is implanted, there will be less anatomical support of the construct at that level due to soft tissue resection.This means there will be less load sharing between the construct and the anatomy at this location.As such, the forces on the construct are larger at that level.One side of the construct had a rod spanning the level with the interbody, while the other side utilized the axial connector as shown in the x-rays.The axial forces on the construct would be transferred to the rod-connector interface.When the patient bent over, high forces were placed on the rod connector construct causing the rod to slip axially.

• Brand Name: AXIAL ROD CONNECTOR, 5.5 X 5.5 X 30 MM (TI-6AL-4V ELI)
• Type of Device: 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: 6859344
• MDR Text Key: 85825860
• Report Number: 2027467-2017-00071
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 47008-55-030
• Device Catalogue Number: 47008-55-030
• Device Lot Number: 7442805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 08/15/2017
• Supplement Dates FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2015
• 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): Hospitalization
• Patient Age: 56 YR