MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE; RISE SPACER, 12X30MM, 10-17MM

Model Number	193.213
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation.Images of the implant after removal were provided.There is damage to the back end of the implant, which may have occurred when trying to remove the implant during repositioning as the cage detached from the inserter during repositioning.It is unclear what could have caused the cage to disassociate itself from the inserter.It is possible excessive force was used to reposition the implant, causing it to detach.Because the spacer was detached from the inserter, it was stated that it was too difficult to remove the implant, thus the implant was left in the patient which required revision surgery to retrieve it.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery was needed to retrieve a rise spacer that had been left in the patient post operatively.This event occurred in japan.

• Brand Name: RISE
• Common Device Name: RISE SPACER, 12X30MM, 10-17MM
• 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: 18837332
• Report Number: 3004142400-2023-00180
• Device Sequence Number: 7486382
• Product Code: MAX
• UDI-Device Identifier: 00889095213669
• UDI-Public: 00889095213669
• 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: 2023
• Device Explanted Year: 2023
• 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): 03/02/2024

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: 193.213
• Device Lot Number: AXV073PE
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2018
• 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: 58 YR
• Patient Sex: Male
• Patient Race: Asian