MAUDE Adverse Event Report: ORTHOFIX FIREBIRD SCREW

Device Problems Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 01/04/2017

Event Type  malfunction  

Event Description

Recurrent lumbar degenerative disc disease.Has had two interventions before thus will need fusion; l3 to l5 redo laminectomy and fusion.He developed new bilateral sciatic pain post surgery ct of the l-spine shows that both of his cages are extruded from the disc space and are compressing the thecal sac.Will return to surgery.

• Brand Name: FIREBIRD SCREW
• Type of Device: SCREW
• Manufacturer (Section D): ORTHOFIX; 3451 plano pkwy.; lewisville TX 75056
• MDR Report Key: 6521892
• MDR Text Key: 73900946
• Report Number: MW5069325
• 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: 58 YR