MAUDE Adverse Event Report: PARADIGM SPINE COFLEX INTERLAMINAR; PROSTHESIS, SPINOUS PROCESS SPACER

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Date 10/21/2014

Event Type  Injury  

Event Description

As per the paradigm spine marketing and a recent retrospective review, i implanted a coflex interspinous dynamic stabilization device at l4/5 in the setting of a stable grade i spondylolisthesis.The patient improved for 8 months.After 8 months, he became unstable, had>4mm on flexion extension views that was no present pre implant and developed worsening back and leg pain.He now has to be revised with a fusion.He was 9 months out from surgery and developed this complication.

• Brand Name: COFLEX INTERLAMINAR
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER
• Manufacturer (Section D): PARADIGM SPINE; 505 park ave.; 14th floor; 10022
• MDR Report Key: 4217323
• MDR Text Key: 18870541
• Report Number: MW5038895
• Device Sequence Number: 1
• Product Code: NQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 91