MAUDE Adverse Event Report: LIFE SPINE ARX; PROBE

Catalog Number	175-100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the returned device and the description of the reported event, it is hypothesized that the root cause of the failure mode was insufficient mechanical properties to withstand the applied forces.The fracture appears through the distal tip of the instrument; this is the thinnest portion of the shaft and would be the region to break under stress.The shaft of the instrument is also bent suggesting that it was loaded off axis from the embedded portion.The patient may have possessed dense bone, which could increase the force necessary to insert the instrumentation.
Event or Problem Description
It was stated that, "tapped the back of the probe with a cobb and the probe snapped.Picture on the left sidez-ray is the ball point feeler inside the pedicle along with tip of gearshift probe that broke off.Right side x-ray is piece that broke off in patient.".

• Brand Name: ARX
• Common Device Name: PROBE
• Manufacturer (Section D): LIFE SPINE; 13951 s. quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 s. quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 25056361
• Report Number: 3004499989-2026-00020
• Device Sequence Number: 10180139
• Product Code: KWQ
• UDI-Device Identifier: 00190837035785
• UDI-Public: (01)00190837035785
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200070
• 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
• Report Date (Section B): 05/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 175-100
• Device Lot Number: CNW23081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male