MAUDE Adverse Event Report: CTL MEDICAL CORPORATION PICASSO II; SET SCREW

Catalog Number 019.1010

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/15/2022

Event Type  malfunction  

Event Description

No injury to the patient or extended delay occurred do to this incident.Because, no x-ray's, patient anatomy, or implants were provided this incident will be filed as indeterminate.However, based on user feedback and conversation with the surgical rep.Potential causes for this incident can be speculated.The subject set screw was implanted into the l5 vertebral body, the middle of the l4-s1 construct, the rod was not fully reduced and seated prior to the mis tower being broken.In a conversation with the surgical rep.It was stated that the rod was particularly difficult to reduce and the construct geometry was severely curved.It is likely that the excessive upward spring force caused by the miss matched patient/construct geometry did not allow the rod and therefor set screw to be fully seated into the screw housing.When construct geometry and patient anatomy do not align in such a way large amounts of potential energy can build up in the construct, when the mis tower is broken while the set screw/rod was not fully seated there is potential that the set screw will pop out of place.Additionally, it is known that the mis dilator was used to break the mis tower which out outside of the prescribed uses.This technique could have also caused the tower to splay open allowing the unseated set screw to move out of place.The screw set screw was removed and replaced.There was no harm nor injury reported to the patient.Overall the withotu additional images or parts to be returned all items before a speculative and the case is deemed indeterminate.

• Brand Name: PICASSO II
• Type of Device: SET SCREW
• 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: 16163172
• MDR Text Key: 308483060
• Report Number: 3009051471-2022-00018
• Device Sequence Number: 1
• Product Code: HWC
• 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: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 019.1010
• 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