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

Model Number	11-0013
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that while cannulating the patient's pelvis, the surgeon felt a snap.When he pulled the instrument out, he found that the tip of the probe had snapped off.The surgeon proceeded with navigation.Approximately 10 mm of the instrument tip was left 110mm deep in the patient's pelvis.No patient injury was reported.No revision surgery is necessary.
Additional Manufacturer Narrative
The instrument was not returned for evaluation as it was disposed of by the hospital.Lot information was not provided by the reporter.No definitive root cause could be established.

• Brand Name: 7D SURGICAL PEDICLE PROBE (LUMBAR)
• Common Device Name: PEDICLE 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: 21564523
• Report Number: 3012098629-2025-00002
• Device Sequence Number: 9216504
• Product Code: OLO
• UDI-Device Identifier: 00628341520027
• UDI-Public: 00628341520027
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K162375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/10/2025
• 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 Sex: Unknown