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

Model Number UNKNOWN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 07/28/2023

Event Type  Injury  

Manufacturer Narrative

The implant has not returned for evaluation.Radiograph images were not provided.The event could not be confirmed.Neither the part number nor the lot number were provided.The root cause could not be determined.If additional information is provided, a supplemental report will be submitted.

Event Description

A male patient underwent a transforaminal lumbar interbody fusion at l4-s1 on an unknown date.Around 8-weeks post-op, the patient stood up and heard a pop.Radiograph images revealed a tulip dislocation at s1.Revision surgery is planned.

• 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: 17627307
• MDR Text Key: 322020871
• Report Number: 2027467-2023-00053
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192938
• 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: 08/25/2023

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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/25/2023
• 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: 46 YR
• Patient Sex: Male