MAUDE Adverse Event Report: ORTHOFIX FIREBIRD SCREW

Device Problem Malposition of Device (2616)

Patient Problems Hematoma (1884); Stenosis (2263); No Code Available (3191)

Event Date 02/08/2017

Event Type  malfunction  

Event Description

The patient reports the symptoms of low back pain and bilateral left to right lower extremity pain s/p an l4-l5 laminectomy and fusion with epidural hematoma performed on (b)(6) 2017.He is also s/p revision l4 laminectomy with medial facetectomy on the left, redo l4-l5 discectomy with tlif cage placement, allograft, screws and rods performed on (b)(6) 2017 performed in treatment of a recurrent left sided disc herniation at l4-l5 with foot drop and severe lumbar stenosis and reexploration of wound and evacuation of hematoma and repositioning of tlif cage utilizing fluoroscopy performed on (b)(6) 2017.The device used resulted in displacement from the disc and kick-back into spinal canal requiring revision surgery.

• Brand Name: FIREBIRD SCREW
• Type of Device: SCREW
• Manufacturer (Section D): ORTHOFIX; 3451 plano pkwy.; lewisville TX 75056
• MDR Report Key: 6521801
• MDR Text Key: 73826371
• Report Number: MW5069314
• Device Sequence Number: 2
• Product Code: NKB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/11/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR