MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÀRL VIPER; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186731745

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2020

Event Type  malfunction  

Event Description

Pedicle screw failure.Left side rod popped out at l4 to s1.The tulip head screws popped.This is a similar event to report # 2201100000-2020-8005.

• Brand Name: VIPER
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÀRL; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9915535
• MDR Text Key: 186133190
• Report Number: 9915535
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 186731745
• Device Catalogue Number: 186731745
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2020
• Event Location: Home
• Date Report to Manufacturer: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Weight: 125