MAUDE Adverse Event Report: CTL AMEDICAL PICASSO II MIS PEDICLE SCREW SYSTEM, T-HANDLE, TORQUE LIMITING, 1/4" SQUARE QC,

Model Number	100.2023
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dr.(b)(6) performed a 2-level (l2-l4) and 1-level (l5-s1) fusion on (b)(6) 2018 using the picasso ii system.During a post-op mri ((b)(6) 2019) it was observed that the set screw had backed out of the pedicle screw housing of one of the screws at the l5 level (error! reference source not found.).From the scans provided, it could not be determined if it was the left side or right side screw.A revision surgery was conducted on (b)(6) 2019.The l5 and s1 pedicle screws, set screws and rod of the affected side were removed and not replaced.The removed parts were not returned to ctl amedica for analysis.At 2 weeks post-op (from revision surgery), the patient notes stated: "sig.Decrease in pain.Not legs sxs or weakness.I've never been this good.Walking 5 miles per day".An engineering analysis report has been attached with this report.[(b)(4)].
Event or Problem Description
When reviewing post op x-ray, noticed set screws were backing out- more info will be provided on case specific and time line from surgery date.

• Brand Name: PICASSO II MIS PEDICLE SCREW SYSTEM, T-HANDLE, TORQUE LIMITING, 1/4" SQUARE QC,
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): CTL AMEDICAL; 4550 excel parkway; suite 300; addison TX 75001
• MDR Report Key: 8422972
• Report Number: 3009051471-2019-00016
• Device Sequence Number: 14209742
• Product Code: NKB
• UDI-Device Identifier: 00841732101326
• UDI-Public: 00841732101326
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100.2023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Required Intervention