MAUDE Adverse Event Report: PARADIGM SPINE GMBH COFLEX (R) INTERLAMINAR TECHNOLOGY

Model Number UQI00010

Device Problem Insufficient Information (3190)

Patient Problem Inadequate Osseointegration (2646)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

Surgery (b)(6) 2014.Two level coflex l3-l4 and l4-l5.Coflex device l3-l4 migrated posterior approximately 1.0 cm visualized on post-op x-ray on a pt follow-up visit.The physician wishes to continue observing and may consider re-op and/or revision.

• Brand Name: COFLEX (R) INTERLAMINAR TECHNOLOGY
• Manufacturer (Section D): PARADIGM SPINE GMBH
• Manufacturer Contact: eisenbahnstrasse 84; wurmlingen 78573 ; 4619635992
• MDR Report Key: 4762899
• MDR Text Key: 16539561
• Report Number: 3005725110-2015-00001
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2015

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
• Device Expiration Date: 01/01/2019
• Device Model Number: UQI00010
• Device Catalogue Number: UQI00010
• Device Lot Number: 2014000074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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): Other