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

Model Number 15100

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 11/09/2022

Event Type  Injury  

Event Description

At 6-months postoperatively, a radiograph revealed a set screw had backed out of an iliac bolt.A revision surgery was performed on (b)(6) 2022 to remove and replace the set screw.

Manufacturer Narrative

The implant was used for treatment, not diagnosis.It did not return to alphatec for evaluation.Radiographs were provided which confirmed the event.The identifying lot number was not provided; therefore, a review of the device history records could not be conducted.Based on the information provided, a root cause could not be determined.If additional information is provided, a supplemental report will be submitted.Labeling review: "intraoperativemanagement: final tightening of set screws: all set screws must be tightened using the appropriate instruments (e.G., torque handle, final driver, and counter torque) as indicated in the surgical technique guide.Warnings/cautions/precautions: risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury.Do not final tighten under compression or distraction as the rod may not be normalized to the tulips, resulting in rod slippage.Failure to tighten set screws using the recommended instrument(s) could compromise the mechanical stability of the construct.Possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon must be discussed with the patient preoperatively.1.Initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.]".

• Brand Name: INVICTUS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vide roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vide roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vide roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 16164288
• MDR Text Key: 307464835
• Report Number: 2027467-2022-00107
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190376137902
• UDI-Public: (01)00190376137902
• 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: 01/13/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/13/2023
• 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 Sex: Male