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

Model Number UQI00014

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Stenosis (2263)

Event Date 11/29/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, the patient underwent a decompressive lumbar semilaminectomy, bilateral, l4-5, with subarticular recess decompression and posterior segmental instrumentation, l4-5, interlaminar spinous process distraction device coflex, size 14mm.The patient initially did well and then developed recurrence of the radiculopathy on the right.Diagnostic studies demonstrated collapse of the coflex device and subsidence into the spinous processes.The patient had weak or osteoporotic bone and the bone subsided.There was no problem with the device.The patient underwent a decompressive lumbar semilaminectomy, l4-5, right, with complete facetectomy, neurolysis, and insertion of interbody fusion cage (tlif), and removal of the coflex on (b)(6) 2016.

Event Description

On (b)(6) 2016, the patient underwent a decompressive lumbar hemilaminectomy, bilateral, l4-5, with subauricular recess decompression and posterior segmental instrumentation, l4-5, interlaminar spinous process distraction device coflex, size 14mm.The patient initially did well and then developed recurrence of the radiculopathy on the right.Diagnostic studies demonstrated collapse of the coflex device and subsidence into the spinous processes.The patient had weak or osteoporotic bone and the bone subsided.There was no problem with the device.The patient underwent a decompressive lumbar hemilaminectomy, l4-5, right, with complete facetectomy, neurolysis, and insertion of interbody fusion cage (tlif), and removal of the coflex on (b)(6) 2016.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• 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: 6197826
• MDR Text Key: 63059884
• Report Number: 3005725110-2016-00007
• 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: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/22/2016

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: 08/31/2019
• Device Model Number: UQI00014
• Device Catalogue Number: UQI00014
• Device Lot Number: 2014002352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• 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: 70 YR
• Patient Weight: 74