MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE; RISE SPACER 10X30MM, 8-15MM, 10°

Model Number	193.123
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a rise spacer collapsed approximately one month post-operatively.Revision surgery was required.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Comparison of the post-operative and follow-up images provided, does indicate a loss of height of the spacer.Evaluation of the returned device found some discoloration which is consistent with what would be expected after having been implanted for over one year.In addition, the back component where the inserter mates with the spacer, appears to be scratched.Apart from the discoloration and scratch, none of the components appear to be damaged in any way.The exact cause of the reported issue cannot be determined.

• Brand Name: RISE
• Common Device Name: RISE SPACER 10X30MM, 8-15MM, 10°
• 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: 18828879
• Report Number: 3004142400-2019-00018
• Device Sequence Number: 7785844
• Product Code: MAX
• UDI-Device Identifier: 00889095213584
• UDI-Public: 00889095213584
• 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 Explanted Year: 2019
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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
• Device Model Number: 193.123
• Device Lot Number: BAS356UD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2015
• 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: 72 YR
• Patient Sex: Female
• Patient Race: White