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

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 11/28/2017

Event Type  Injury  

Event Description

Coflex implant removal.The cause of removal was due to reoccurrence of backpain.Mri showed fluid between the facets.The fluid can cause instability, resulting in backpain coflex was removed, revision laminectomy was performed and a new coflex implant implanted.

• Brand Name: COFLEX INTERLAMINAR TEHCNOLOGY
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): PARADIGM SPINE GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• Manufacturer (Section G): PARADIGM SPINE GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• Manufacturer Contact: alberto jurado ; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• MDR Report Key: 7141570
• MDR Text Key: 95591116
• Report Number: 3005725110-2017-00008
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2017

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2017
• 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