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

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); No Information (3190)

Event Date 01/29/2020

Event Type  malfunction  

Event Description

Coflex implant removal due to a broken implant wing.

Event Description

Coflex implant removal due to a broken implant wing.Surgeon explanted both coflex implants in l3-4 and l4-5 and removed a fractured l4 spinous process.

Manufacturer Narrative

The surgeon reported that the patient was non-compliant and did things they told him not to do.The nurse did confirm that the patient did pick up a cooler and threw it into the back of his truck with a twisting motion and felt a pop.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER
• Manufacturer (Section D): PARADIGM SPINE GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• MDR Report Key: 9763543
• MDR Text Key: 209412847
• Report Number: 3005725110-2020-00001
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 109