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

Model Number UQI00010

Device Problem Insufficient Information (3190)

Patient Problem Abscess (1690)

Event Date 08/25/2015

Event Type  Injury  

Event Description

Pt developed an epidural abscess (infection).

• Brand Name: COFLEX
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER
• Manufacturer (Section D): PARADIGM SPINE GMBH; wisenbahnstrasse 84; wurmlingen 78573 ; GM 78573
• Manufacturer (Section G): PARADIGM SPINE LLC; eisenbahnstrasse 84; wurmlingen 78573 ; GM 78573
• Manufacturer Contact: alberto jurado ; eisenbahnstrasse 84; wurmlingen 78573 ; GM 78573
• MDR Report Key: 5197133
• MDR Text Key: 30338559
• Report Number: 3005725110-2015-00007
• 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: unknown
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2015

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: Other
• Device Expiration Date: 02/28/2019
• Device Model Number: UQI00010
• Device Catalogue Number: UQI00010
• Device Lot Number: 2014000523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2015
• Initial Date FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2014
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention