MAUDE Adverse Event Report: 7D SURGICAL ULC 7D SURGICAL SYSTEM; NAVIGATION SYSTEM

Model Number	10-0001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Limb Pain (4836)
Type of Reportable Event	Serious Injury
Event or Problem Description
On 23 feb 2026, orthofix received an article which states that at five weeks postoperatively, the patient developed progressive right arm pain and weakness.Ct/mri imaging found bilateral c2 laminar fractures with screw loosening and cord impingement.As a result, the patient underwent a revision surgery with screw removal and extension of fusion down to c4.After 5 weeks of inpatient rehabilitation, he could walk with assistance.
Additional Manufacturer Narrative
Quality compliance will continue to monitor for similar reports as part of routine post-market surveillance.

• Brand Name: 7D SURGICAL SYSTEM
• Common Device Name: NAVIGATION SYSTEM
• Manufacturer (Section D): 7D SURGICAL ULC; 60 scarsdale road; unit 118; toronto, ontario M3B 2 R7; CA M3B 2R7
• Manufacturer (Section G): 7D SURGICAL ULC; 60 scarsdale road; unit 118; toronto, ontario M3B 2 R7; CA M3B 2R7
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 24676576
• Report Number: 3012098629-2026-00003
• Device Sequence Number: 10359919
• Product Code: OLO
• UDI-Device Identifier: 00628341520379
• UDI-Public: 00628341520379
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10-0001
• Device Catalogue Number: 10-0001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male