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

Device Problem Unstable (1667)

Patient Problem Cyst(s) (1800)

Event Type  No Answer Provided  

Event Description

A previously stable grade 1 l4/5 spondy turned into an unstable one.Mr imaging showed facet joint cyst.Pt requires fusion.

• Brand Name: COFLEX INTERLAMINAR TECHOLOGY
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER
• Manufacturer (Section D): PARADIGM SPINE GMBH
• Manufacturer Contact: eisenbahnstrasse 84; wurmlingen 78573 ; 4619359927
• MDR Report Key: 4290278
• MDR Text Key: 5054574
• Report Number: 3005725110-2014-00007
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• PMA/PMN Number: P110008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Type of Report: Initial
• Report Date: 11/21/2014

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2014
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention