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

Model Number 15420-11

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The device has not returned.If any additional information is provided, a supplemental report will be submitted.

Event Description

On (b)(6) 2021, a patient underwent a posterior lumbar spinal fusion surgery.Four months postoperatively, it was reported a screw disassociated from the pivoting connector.No patient injury reported.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: jayson alaba ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946771
• MDR Report Key: 12640712
• MDR Text Key: 276681052
• Report Number: 2027467-2021-00067
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190376283869
• UDI-Public: (01)00190376283869
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203056
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 15420-11
• Device Catalogue Number: 15420-11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• 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