MAUDE Adverse Event Report: PARADIGM SPINE COFLEX; SPINE PROTHESIS

Model Number UQI00012

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 04/04/2016

Event Type  Injury  

Event Description

Patient's spine deteriorated around coflex implant.

• Brand Name: COFLEX
• Type of Device: SPINE PROTHESIS
• Manufacturer (Section D): PARADIGM SPINE; new york NY 10022
• MDR Report Key: 5553836
• MDR Text Key: 42179396
• Report Number: MW5061525
• Device Sequence Number: 1
• Product Code: NQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: UQI00012
• Device Lot Number: 2014001827
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 82