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

Model Number	UQI00012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Stenosis (2263)
Date of Event	04/04/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Coflex revision surgery - the patient's spine deteriorated around coflex implant.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER
• Manufacturer (Section D): PARADIGM SPINE GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• MDR Report Key: 5705399
• Report Number: 3005725110-2016-00004
• Device Sequence Number: 18835573
• Product Code: NQO
• UDI-Device Identifier: 04260148898525
• UDI-Public: (01)04260148898525(17)190630(10)2014001827
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P110008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2016

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
• Operator of Device: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: UQI00012
• Device Catalogue Number: UQI00012
• Device Lot Number: 2014001827
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2016
• Initial Report FDA Received Date: 06/08/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR