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	Foreign Body In Patient (2687)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 22 jul 2026 orthofix was made aware of an event involving the 7d surgical pedicle probe (lumbar) fracturing during a lumbar fusion revision procedure.The reporter stated that while advancing the probe through highly sclerotic sacral bone, the shaft of the probe would not rotate with the handle.Upon removal, it was observed that the distal end had twisted, and the tip had fractured off.The fragment remained within the bone.No patient injury was reported.The surgeon did not attempt to retrieve the fragment.
Additional Manufacturer Narrative
The instrument was returned and evaluated.Approximately 5-10mm were missing from the distal tip.Excessive signs of twisting were observed on the remaining tip.Additionally, the weld was fractured between the handle and the shaft.This suggests that excessive torque was applied to the instrument which contributed to the observed failure.

• 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 ; +1(760)216-5655
• MDR Report Key: 50358999
• Report Number: 3012098629-2026-00005
• Device Sequence Number: 15999906
• Product Code: OLO
• UDI-Device Identifier: 00628341520027
• UDI-Public: 00628341520027
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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: 11-0013
• Device Catalogue Number: 11-0013
• Device Lot Number: 0245
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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