MAUDE Adverse Event Report: CTL MEDICAL CORPORATION PICASSO II; ROD

Model Number 016.3110

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 11/02/2022

Event Type  malfunction  

Event Description

A 6.0mm diameter by 110mm rod was inserted into the mis screw slot.To set the rod in place within the tulip heads, additional pressure was applied to the rod, which ultimately resulted in the separation of the rod's proximal fixation point with the rod inserter and the distal shaft.The resulting parts were removed from the patient and replaced.This caused a 5 minute delay in surgery.Shared images of broken rod/instrument interface tip points to excessive lever force.No surgical technique was shared by the end user; therefore, usage modality is indeterminate.The subject rod function as a bridge that passes through the skin and sits into multiple spacially aligned bone-anchored screw housings.Excessive pressure for rod insertion into a housing by an end-user tentatively points to a questionable placement of screws, degree of patient anatomy, and/or user technique.No x-ray images, parts, patient anatomy, or detailed user steps were provided.No harm or injury to the patient is reported but a minor delay.Without additional evidence(s), this claim is indeterminate.

• Brand Name: PICASSO II
• Type of Device: ROD
• 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: 16146517
• MDR Text Key: 308497874
• Report Number: 3009051471-2022-00014
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 016.3110
• Device Lot Number: 15A5.WBBA
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1