MAUDE Adverse Event Report: CTL MEDICAL CORPORATION RAPHAEL; PROBE

Model Number 015.7022

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2019

Event Type  malfunction  

Event Description

A probe was used initially and left in place while a burr was used afterwards.Distal tip of the pedicle probe was caught on a burr which caused a divot on the tip of the probe.Probe was removed from the bone and procedure was carried out as usual.There is no injury nor harm to the patient.Surgery was completed without issue.No further information provided, user error.Part was not returned.Non-forseeable use by end user combining a powertool while another instrument was present at the surgical site.

• Brand Name: RAPHAEL
• Type of Device: PROBE
• Manufacturer (Section D): CTL MEDICAL CORPORATION; 4550 excel parkway; addison TX 75001
• Manufacturer (Section G): CTL MEDICAL CORPORATION; 4550 excel parkway; addison TX 75001
• Manufacturer Contact: tracy bui ; 4550 excel parkway; addison, TX 75001
• MDR Report Key: 15723372
• MDR Text Key: 304591710
• Report Number: 3009051471-2019-00012
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 015.7022
• Device Lot Number: SBBEP23C
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1