MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE EXPANDABLE SPACER; RISE SPACER, 8X22MM, 7-13MM

Model Number	193.001
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the subject device found the implant in the expanded state.Superficial scratches were noted on the anodizing that are likely the result of retrieving the implant during the revision surgery.The imaging provided shows the implant to have shifted outside the disc space.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported there was a revision surgery to replace a rise spacer that migrated post operatively.This event occurred in japan.

• Brand Name: RISE EXPANDABLE SPACER
• Common Device Name: RISE SPACER, 8X22MM, 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: 15803986
• Report Number: 3004142400-2022-00165
• Device Sequence Number: 20237133
• Product Code: MAX
• UDI-Device Identifier: 00889095213416
• UDI-Public: 00889095213416
• 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: 2022
• Device Explanted Year: 2022
• 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): 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 193.001
• Device Lot Number: AXA165YG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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: Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: Asian