MAUDE Adverse Event Report: CTL MEDICAL CORPORATION RAPHAEL PEDICLE SCREW 6.5X35

Model Number	015.3237
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow-up mri indicates that tulip has separated from rod.In reviewing the images, it appears that tulip may have separate from screw body.No revision surgery was performed.The patient is doing fine.
Event or Problem Description
Follow-up mri indicates that tulip has separated from rod.In reviewing the images, it appears that tulip may have separate from screw body.The implanted device was not removed, revision surgery did not occur.The patient is doing fine.

• Brand Name: RAPHAEL PEDICLE SCREW 6.5X35
• Common Device Name: RAPHAEL PEDICLE SCREW 6.5X35
• Manufacturer (Section D): CTL MEDICAL CORPORATION; 4550 excel parkway; suite 300; addison TX 75001
• MDR Report Key: 7987311
• Report Number: 3009051471-2018-00008
• Device Sequence Number: 11076639
• Product Code: MNI
• UDI-Device Identifier: 00841732119772
• UDI-Public: 00841732119772
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2018

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 Model Number: 015.3237
• Device Catalogue Number: 015.3237
• Device Lot Number: 7KNBB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR