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

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 04/29/2014

Event Type  malfunction  

Event Description

Revision surgery due to coflex wing breakage - patient had some low back pain, wing of the device noted to be broken.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Type of Device: PROSTHESIS SPINOUS PROCESS SPACER
• Manufacturer (Section D): PARADIGM SPINE GMBH
• Manufacturer Contact: eisenbahnstrasse 84; wurmlingen 78573 ; 4619635992
• MDR Report Key: 4360904
• MDR Text Key: 5113944
• Report Number: 3005725110-2014-00009
• 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: Physician
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2014
• 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
• Patient Age: 64 YR