MAUDE Adverse Event Report: 7D SURGICAL ULC 7D SURGICAL PEDICLE PROBE (LUMBAR); LUMBAR PROBE

Model Number	11-0013
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 7d surgical pedicle probe (lumbar) has not been returned for evaluation.Events logs were requested but have not been provided.Quality compliance will continue to monitor for similar complaints as part of routine post-market surveillance.
Event or Problem Description
On 30 jul 2025, orthofix was made aware of the following event during navigation using 7d surgical flash imaging.Per the reporter, the surgeon navigated the right t10 and right t9 screws using the 7d surgical pedicle probe (lumbar).The surgeon complained of the probes inaccuracy and switched to another probe to complete the remaining screw navigation.After all screws were implanted, an x-ray was taken, revealing that the t10 and t9 screws were incorrectly positioned.The two screws were revised, resulting in a 45 min surgical delay.No patient injury was reported.
Additional Manufacturer Narrative
The 11-0013 7d surgical pedicle probe (lumbar) was received and evaluated by engineering.Tool verification and accuracy evaluations were successfully performed.The instrument was accurate under navigation.The root cause could not be determined; however, the following could have contributed to probe inaccuracy: 1.Degraded marker spheres 2.Levering of the probe while cannulating the hole 3.Unknown environmental factors (such as ir interference).

• Brand Name: 7D SURGICAL PEDICLE PROBE (LUMBAR)
• Common Device Name: LUMBAR PROBE
• 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: 22913121
• Report Number: 3012098629-2025-00009
• Device Sequence Number: 9130746
• Product Code: OLO
• UDI-Device Identifier: 00628341520027
• UDI-Public: 00628341520027
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2025

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: 11-0013
• Device Catalogue Number: 11-0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 11/27/2025; 12/08/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 12/08/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 10-0001 7D SURGICAL SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown