MAUDE Adverse Event Report:; NONE

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 06/05/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, pt identified by x-ray to have s1 pedicular screw fracture.On (b)(6) 2015, pt underwent the following operative procedures: l4, l5 and s1 laminectomies and bilateral facetectomies.Harvesting of posterior spinal elements from l4, l5 and s1 for use as autograft; l4, l5 and s1 posterior segmental instrumentation using reliance medical pedicle screw system; l4, l5, and s1 posterior and posterolateral arthrodesis.Placement of morselized autograft, vancomycin powder and allograft along the decorticated bone of l4, l5, and s1 bilaterally.Intraoperative fluoroscopy.Will contact manufacturer subsequent to this report.

• Type of Device: NONE
• MDR Report Key: 5005260
• MDR Text Key: 23215989
• Report Number: 5005260
• Device Sequence Number: 1
• Product Code: MCV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2015
• Distributor Facility Aware Date: 06/23/2015
• Event Location: Other
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR