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

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2018

Event Type  Injury  

Event Description

Coflex removal due to implant breakage.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER
• 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: 8069199
• MDR Text Key: 127128517
• Report Number: 3005725110-2018-00004
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention