MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SABLE; SABLE SPACER, 10X30, 6-12MM, 8°

Model Number	1172.2210S
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a sable spacer was found to be deformed six weeks post operatively.
Additional Manufacturer Narrative
The device was not available for evaluation as it remains in the patient.The patient went in for a routine 6 week follow up and post-op x-ray showed the implant appearing to have deformed.It was stated that the patient did not experience any trauma (fall or other excessive external forces) that could have contributed to the issue.The implant has been left in the patient.The x-ray image shows superior vertebrae not contacting the front portion of the implant because the front portion of the superior vertebral endplate is missing.It is possible this unique anatomy could have contributed to the complaint, but based off the information given, no determinations could be made as to the cause of the reported issue.

• Brand Name: SABLE
• Common Device Name: SABLE SPACER, 10X30, 6-12MM, 8°
• 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: 18520187
• Report Number: 3004142400-2024-00009
• Device Sequence Number: 12450424
• Product Code: MAX
• UDI-Device Identifier: 00889095966107
• UDI-Public: 00889095966107
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K222270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 01/16/2024

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: 1172.2210S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/16/2024
• 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