MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE; RISE SPACER, 10X26MM, 7-14MM

Model Number	193.102
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device or any imaging could be provided for evaluation.Additional information provided that a fall that the patient experience between the initial surgery and a post-operative follow up may have cause or contributed to the migration.However, an exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that a rise cage has migrated posteriorly 1 year post operatively.

• Brand Name: RISE
• Common Device Name: RISE SPACER, 10X26MM, 7-14MM
• 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: 14985938
• Report Number: 3004142400-2022-00110
• Device Sequence Number: 13849083
• Product Code: MAX
• UDI-Device Identifier: 00889095213515
• UDI-Public: 00889095213515
• 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
• 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): 07/07/2022

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: 193.102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown