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

Model Number UNKNOWN

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 02/10/2023

Event Type  Injury  

Manufacturer Narrative

The implants are used for treatment, not diagnosis.A postoperative radiograph image was provided which confirmed the event.The explanted implants did not return for evaluation.The original surgery date is unknown.Neither the part nor lot number were provided.The udi number is unknown.A review of the device history records could not be completed.Based on the information provided, the root cause could not be determined.A good faith effort will be made to obtain additional information.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported a screw at l4 pulled out of the construct postoperatively causing the cage to migrate.A revision surgery was performed on an unknown date in february 2023.

• 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: 16518274
• MDR Text Key: 311036821
• Report Number: 2027467-2023-00016
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221926
• 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
• Report Date: 03/09/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/09/2023
• 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 Age: 75 YR
• Patient Sex: Male