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

Model Number UQI00016

Device Problem No Apparent Adverse Event (3189)

Patient Problem Cyst(s) (1800)

Event Date 03/03/2016

Event Type  No Answer Provided  

Event Description

Facet cyst required removal of implant to get the cyst.Implant was not put back in.The patient has a grade 1 spondy at l5-s1, and a grade 1 to 2 spondy with around 8 mm of subluxation at l4-l5.Hence the device is used off label.The surgery was at l4-l5 and only involved a unilateral decompression.The facet cyst occurred on the side that did not have decompression at l4-l5.The patient probably has pars defects at l5-s1 that propagated the instability because the l5 lamina supporting the coflex was "floating" and not a stable support for the device.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACE
• 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: 5549659
• MDR Text Key: 41937315
• Report Number: 3005725110-2016-00003
• 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: Medical Assistant
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: UQI00016
• Device Catalogue Number: UQI00016
• Device Lot Number: 2013003624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2016
• Initial Date FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 79