MAUDE Adverse Event Report: DEPUY SPINE INC MIS TI CFX FEN POLY 12X50; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number 186727250

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 06/23/2023

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: reporter came through post market; no facility or contact available.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported through post market studies increased pain was experienced in the back of a patient with a spine procedure.The date of procedure was (b)(6) 2023 with levels l2-l3 treated with cage and construct.Post-operatively patient experienced increased back pain possibly linked to the initial procedure.This report is for one mis ti cfx fen poly 12x50 for (b)(4).

• Brand Name: MIS TI CFX FEN POLY 12X50
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18909277
• MDR Text Key: 337729367
• Report Number: 1526439-2024-01054
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 186727250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MIS TI CFX FEN POLY 12X50.; POST IBF UI H 10MM 8DEG 22/9.; SINGLE-INNER SETSCREW.
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female