MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE; RISE SPACER, 10X26MM, 8-15MM, 10°

Model Number 193.122

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/24/2020

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported by a representative from the (b)(6) that a revision surgery was done to remove a rise cage and replace it with a smaller footprint.

• Brand Name: RISE
• Type of Device: RISE SPACER, 10X26MM, 8-15MM, 10°
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 11181190
• MDR Text Key: 231415560
• Report Number: 3004142400-2021-00013
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00889095213577
• UDI-Public: 00889095213577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 193.122
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other