MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE-L; RISE-L SPACER 18 X 40MM, 10-17MM, 10°

Model Number	193.332
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device has not been returned for evaluation.Images taken directly post-operatively and after three months were provided and indicate that the spacer inserter into the l2-l3 disc space has lost height.The implant remains in the patient making a complete evaluation impossible.The exact cause of the reported issue cannot be determined.
Event or Problem Description
It was reported that a rise-l spacer has lost height post-operatively.

• Brand Name: RISE-L
• Common Device Name: RISE-L SPACER 18 X 40MM, 10-17MM, 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: 18831630
• Report Number: 3004142400-2018-00057
• Device Sequence Number: 3076204
• Product Code: MAX
• UDI-Device Identifier: 00889095213935
• UDI-Public: 00889095213935
• 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: 2018
• 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): 03/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: 193.332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 03/04/2024
• 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