MAUDE Adverse Event Report: ALPHATEC SPINE, INC INVICTUS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 15100

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 03/22/2023

Event Type  Injury  

Manufacturer Narrative

The returned devices are currently being evaluated.A follow-up report with results of the investigation will be submitted upon completion.

Event Description

It was reported that a set screw had backed out of screw postoperatively.Revision surgery is planned.

Manufacturer Narrative

Model # 15100; lot # sm147376; udi# (b)(4).Model # 15100; lot # sm135852; udi# (b)(4).Model # 15100; lot # sm147238; udi# (b)(4).Model # 17093-090; lot # 8301302-028; udi# (b)(4).Model # 17093-090; lot # 8484704-021; udi# (b)(4).H6.Investigation findings: 3207; investigation conclusion: 44.H8.Initial use of implants; reuse: of torque handles.Radiograph images were provided from the 2-week postoperative visit which confirmed the event.On the left side of the construct 2 or 3 set screws at the superior levels appear to be disengaged.There appears to be 1 set screw mid-construct that is disengaged and 1 set screw at the inferior level which is completely disengaged.The entire construct on the right side is intact and stable.Revision surgery was performed on (b)(6) 2023.The surgeon removed and replaced all the hardware.The explanted hardware and two torque handles were returned to alphatec for evaluation.Visual inspection of the returned explants from the right side all have perfect wear marks confirming none of the set screws backed out.Visual inspection of the explants from the left side are missing lockdown wear marks which indicates they were not torqued properly.The first torque handle pn 17093-090 ln 8301302-028 was tested and failed inspection.It was breaking off at ~38 in-lbs.The handle's torque value is set by compressing a spring stack to a certain height.There are two interfaces that relate to the setting of this spring preload.First is the connection between the torque mechanism assembly and the silicone handle.This is critical to set the proximal end of the spring stack height.If connection started to unthread, the spring preload could be reduced.This threaded connection was properly tightened and secure.The second interface are two tubes that get threaded together and are locked in place via 3 set screws.The relationship between these two threaded components set the axial location of the spring pocket's distal face.When disassembling the instrument, one of the three set screws was stripped and had to be removed using a special tool.The third set screw was likely under torqued which allowed for the threaded carriage to unthread overuse/time, resulting in lower spring preload and therefore loss in the final tightening torque.It is likely this torque handle was used on the left side of the construct.The second torque handle pn 17093-090 ln 8484704-021 passed inspection.It is likely this torque handle was used on the right side of the construct.Review of the device history record indicates qty (b)(4) of pn 17093-090 ln 8301302-028 were manufactured to drawing rev b.There were no manufacturing or processing-related irregularities.They were found to be properly manufactured and released in accordance with design specifications.The device has been in the field since june 24, 2019.Review of the device history record indicates qty (b)(4) of pn 17093-090 ln 848704-021 were manufactured to drawing rev c.There were no manufacturing or processing-related irregularities.They were found to be properly manufactured and released in accordance with design specifications.The device has been in the field since april 30, 2020.Review of the device history record indicates qty (b)(4) of pn 15100 ln sm147376 were manufactured to drawing rev b.There were no manufacturing or processing-related irregularities.They were found to be properly manufactured and released in accordance with design specifications.The device has been in the field since april 29, 2022 review of the device history record indicates qty (b)(4) of pn 15100 ln sm135852 were manufactured to drawing rev b.There were no manufacturing or processing-related irregularities.They were found to be properly manufactured and released in accordance with design specifications.The device has been in the field since october 15,2021.Review of the device history record indicates qty (b)(4) of pn 15100 ln sm147238 were manufactured to drawing rev b.There were no manufacturing or processing-related irregularities.They were found to be properly manufactured and released in accordance with design specifications.The device has been in the field since april 9, 2022.

• Brand Name: INVICTUS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 16796158
• MDR Text Key: 313831925
• Report Number: 2027467-2023-00031
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190376137902
• UDI-Public: (01)00190376137902(10)AP00817
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

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: Health Professional
• Device Model Number: 15100
• Device Catalogue Number: 15100
• Device Lot Number: AP00817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: No
• 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