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

Model Number UQI00010

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 11/02/2015

Event Type  Injury  

Event Description

This case was an adjacent level case to a fusion that had a post op infection and was loosened after exploration and removal.Loosening is the consequence of infection and infection is the net reason for reoperation.

Event Description

This case was an adjacent level case to a fusion that had a post op infection and was loosened after exploration and removal.Loosening is the consequence of infection and infection is the net reason for reoperation.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER
• Manufacturer (Section D): PARADIGM SPINE GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• Manufacturer (Section G): PARADIGM SPINE GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• Manufacturer Contact: alberto jurado ; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573 ; 9746196359
• MDR Report Key: 5317504
• MDR Text Key: 34070823
• Report Number: 3005725110-2015-00008
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 04260148898518
• UDI-Public: (01)04260148898518(17)190630(10)2014001975
• 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,Followup
• Report Date: 01/11/2016

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: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: UQI00010
• Device Catalogue Number: UQI00010
• Device Lot Number: 2014001975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 99