MAUDE Adverse Event Report: AMPLIFY SURGICAL DUALX

Model Number	1294-1001-003
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Spinal deformity (4886)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr.Did not use expandable trial.Dr.Implanted a dualx slim into patient.During expansion surgical site gave audible pop sound during expansion (cannot confirm implant or anatomy).Under lateral xray implant shows expanded and in correct position but posterior portion appears to not be clear of posterior foramen.Lock screw would not thread into nose.Instruments were disconnected from implant in an attempt to get lock screw to thread into nose.Lock screw would not thread into nose.Lock screw was removed.Implant was malleted forward to clear posterior neural elements.Lateral xray shows expanded implant but anterior of the vertebral body.Ap xray shows posterior portion of implant only partially expanded (implant appears to be intact and components not broken or dislocated).Attempts to re-attach instruments to implant failed.Implant left in patient partially laterally expanded and partially vertically expanded without lock screw.

• Brand Name: DUALX
• Common Device Name: DUALX
• Manufacturer (Section D): AMPLIFY SURGICAL; 27092 burbank; foothill ranch CA 92610
• Manufacturer (Section G): AMPLIFY SURGICAL; 27092 burbank; foothill ranch CA 92610
• Manufacturer Contact: clark hutton ; 27092 burbank; foothill ranch, CA 92610 ; 6192458035
• MDR Report Key: 24218202
• Report Number: 3015255331-2025-01040
• Device Sequence Number: 9266089
• Product Code: MAX
• UDI-Device Identifier: B707129410010030
• UDI-Public: +B707129410010030/$$71003528
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 01/25/2026

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
• Operator of Device: Health Professional
• Device Model Number: 1294-1001-003
• Device Catalogue Number: 1294-1001-003
• Device Lot Number: 100352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Female