MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE; RISE SPACER 10X22MM, 7-13MM

Model Number	193.101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was performed to remove a rise spacer which had collapsed.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.It was stated that the surgeon used the rise spacer in t10-t11 with unilateral nuvasive reliance screws as a posterior fixation which is off label use of the device at thoracic levels.It was statnd that during the revision case, the surgeon had to reduce the height of the spacer with the driver, three full turns at minimum, to remove the implant from the disc space.The explanted spacer was visually inspected through two clear plastic bags and was in a mostly collapsed state, roughly 0.5mm of expansion.All of the components appear to be engaging properly with each other without any disassociation.A damage mark was identified on the external corner posterior surfaces of the back ramp.These marks appear to have been caused while explanting the device.A review of the fluoro images show that the spacer was at least partially expanded at the time they were taken.However, without complementary immediate post-operative images or images prior to the spacer removal, it is not possible to determine if there was a loss of height in the rise spacer.

• Brand Name: RISE
• Common Device Name: RISE SPACER 10X22MM, 7-13MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 18825270
• Report Number: 3004142400-2018-00021
• Device Sequence Number: 7720800
• Product Code: MAX
• UDI-Device Identifier: 00889095213508
• UDI-Public: 00889095213508
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 193.101
• Device Lot Number: WTT035BD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female