MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. CD HORIZON® SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Model Number 55840006535

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 03/01/2018

Event Type  malfunction  

Event Description

Left sided pedicle screw broken just below the head.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC.; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 7352178
• MDR Text Key: 102891852
• Report Number: 7352178
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2018

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
• Device Operator: No Information
• Device Model Number: 55840006535
• Other Device ID Number: 55840006535 H5349859
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2018
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR