MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE; RISE SPACER, 10X22MM, 8-14MM, 10°

Model Number	193.121
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor any imaging were available for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported from a representative from japan that a revision surgery was done for a rise spacer which migrated post-operatively with subsequent screw loosening, causing patient pain.

• Brand Name: RISE
• Common Device Name: RISE SPACER, 10X22MM, 8-14MM, 10°
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11859461
• Report Number: 3004142400-2021-00093
• Device Sequence Number: 14553756
• Product Code: MAX
• UDI-Device Identifier: 00889095213560
• UDI-Public: 00889095213560
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 05/13/2021

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: 193.121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Weight: 60