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

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); No Information (3190)

Event Date 01/18/2018

Event Type  Injury  

Event Description

Coflex implant removal due to trauma.Xlif and posterior lumbar fusion were performed.

Event Description

Coflex implant removal due to trauma fall from ground height with spinous process fracture.No implant failure coflex implant did not break or migrate.Xlif and posterior lumbar fusion were performed.

Event Description

Coflex implant removal due to trauma.Patient had a disc fracture.Xlif and posterior lumbar fusion were performed.Coflex implant did not break or migrate.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• 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: 7276038
• MDR Text Key: 100239441
• Report Number: 3005725110-2018-00002
• 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,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• 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
• Date Manufacturer Received: 01/18/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention