MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE; RISE SPACER

Model Number 193.103

Device Problem Collapse (1099)

Patient Problem Insufficient Information (4580)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

The implant remains in the patient, and therefore no evaluation can made.Based on the images provided, there appears to be a partial loss of height.It cannot be determined what the implant's current height is and how it compares to when the implant was implanted.No determinations as to the cause of the partial loss of height can be determined.

Event Description

It was reported that a post-op scan revealed the rise spacer had collapsed.

• Brand Name: RISE
• Type of Device: RISE SPACER
• 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: 7013357
• MDR Text Key: 231416238
• Report Number: 3004142400-2017-00062
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00889095213522
• UDI-Public: 00889095213522
• 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: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 193.103
• Date Manufacturer Received: 10/17/2017
• 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
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 44 KG