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

Model Number UQI00010, UQI00014

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Impotence (1925); Stenosis (2263)

Event Date 09/04/2014

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014 the pt underwent a bilateral hemilaminotomy, facetectomy, foraminotomy at l4-5, l5-s1.Spinal reduction at l4-5.Posterolateral fusion with locally harvested morselized bone and frozen allograft plus insertion of two coflex interlaminar implants at l4-5, l5-s1.On (b)(6) 2014 she was readmitted with loss of bladder control.A semi emergent decompression and pedicle screw stabilization was performed: removal of coflex implants with laminectomy, facetectomy, foraminotomy at l3-4, l4-5, and l5-s1, pedicle screw stabilization l3-s1, tlif fusion at l3-4, l4-5 with spondyloreduction.

Manufacturer Narrative

Implants were used off label used with fusion and at l5-s1.Coflex is not intended to be used as supplement to fusion.Coflex is not intended to be used in l5-s1.Ten days post op the pt had removal of implants and extension of the fusion with complete laminectomy and tlif l3 to s1.The pts appears to have had a post op cauda equina syndrome or epidural hematoma as the pt presented with loss of bladder control.These are technique related complications associated with off label use.

• 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: 4188663
• MDR Text Key: 5099822
• Report Number: 3005725110-2014-00006
• 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: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: UQI00010, UQI00014
• Device Catalogue Number: UQI00010, UQI00014
• Device Lot Number: 2013004556, 2013005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 76 YR