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

Model Number UQI00008

Device Problem Osseointegration Problem (3003)

Patient Problem Pain (1994)

Event Date 11/13/2014

Event Type  No Answer Provided  

Event Description

Coflex explantation due to implant loosening.

• Brand Name: COFLEX (R) 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: 4347513
• MDR Text Key: 5199703
• Report Number: 3005725110-2014-00008
• 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: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: UQI00008
• Device Catalogue Number: UQI00008
• Device Lot Number: 2013004148
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 56 YR
• Patient Weight: 91