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

Model Number 15014-055-040;15100

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2022

Event Type  Injury  

Event Description

Approximately one year postop, the set screws at right t11 and right t12 were noted to be disengaged on radiograph.The patient is asymptomatic.No revision surgery is planned at this time.

Manufacturer Narrative

The implants remain in-situ.The identifying lot numbers were not provided; therefore, a review of the device history records could not be performed.The root cause could not be determined at this time.If additional information is received, a supplemental report will be submitted.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; caarlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 14120424
• MDR Text Key: 289355066
• Report Number: 2027467-2022-00017
• Device Sequence Number: 1
• Product Code: NKB
• 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: 03/16/2022

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?: Yes
• Device Model Number: 15014-055-040;15100
• Device Catalogue Number: 15014-055-040;15100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/15/2022
• 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: 70 YR
• Patient Sex: Female