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

Model Number UQI00014

Device Problem Fracture (1260)

Patient Problem Implant Pain (4561)

Event Date 05/24/2022

Event Type  Injury  

Event Description

The patient was treated with coflex implants in the levels l3/l4 and l4/l5 in 2017 and the patient reported feeling great with no back pain until approximately 2019 when he noted increased back pain.The patient presented to the surgeon a month before the revision surgery and the surgeon recognized the fractured implant at the l4/l5 level in the sagittal radiograph.The surgeon determined that a revision lumbar surgery was the preferred treatment to reduce the patient's pain and restore stability.The implant was removed with additional decompression performed.The surgeon determined the patient had sufficient stability without the need for fusion.

• 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: richard younger jr ; eisenbahnstrasse 84; wurmlingen 78573 ; GM 78573
• MDR Report Key: 14767115
• MDR Text Key: 294490377
• Report Number: 3005725110-2022-00001
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 04260148898532
• UDI-Public: (01)04260148898532(17)210331(10)2016000286
• 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: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: UQI00014
• Device Catalogue Number: UQI00014
• Device Lot Number: 2016000286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2016
• 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: 29 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White