MAUDE Adverse Event Report: PARADIGM SPINE GMBH COFLEX INTERLAMINAR TECHNOLOGY

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

Single level spinous process fracture at the superior level of a 2-level coflex case.Revision surgery (360 degree fusion) was performed 8 months after initial surgery.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Manufacturer (Section D): PARADIGM SPINE GMBH; wurmlingen ; GM
• Manufacturer Contact: eisenbahnstrasse 84; wurmlingen 78573 ; 4619635992
• MDR Report Key: 4787437
• MDR Text Key: 5877515
• Report Number: 3005725110-2015-00002
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• 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: 05/18/2015

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention