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

Model Number UQI00010

Device Problems Break (1069); Device Handling Problem (3265)

Patient Problems Incontinence (1928); Pain (1994)

Event Type  malfunction  

Event Description

Within days of the implantation surgery, the patient heard a large pop in her back.Upon examination, the doctor discovered that the coflex implant fractured.Further, it was at this time that the surgeon confirmed that the coflex device was being used off-label and in a manner not approved by fda.As a result, the patient was forced to undergo a second procedure to remove the fractured implant.She began to experience bladder dysfunction and urinary incontinence.She continues to experience extreme and debilitating back pain,.

• 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
• MDR Report Key: 6816378
• MDR Text Key: 83509129
• Report Number: 3005725110-2017-00004
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 04260148898518
• UDI-Public: (01)04260148898518(17)190731(10)2014002201
• Combination Product (y/n): N
• PMA/PMN Number: P110008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: UQI00010
• Device Catalogue Number: UQI00010
• Device Lot Number: 2014002201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention