MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SABLE; SABLE SPACER, 10X26, 9-16MM, 8°

Model Number	1172.2113S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/09/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported a was sable spacer was removed from a patient who then later died.
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Additional Manufacturer Narrative
The device was not available for evaluation.In the initial surgery, the patient had a prior kyphoplasty with cement at t12, which was the superior vertebral body of the site of intended interbody fusion.It is unknown what screw system was present in the patient due to the kyphoplasty.The initial procedure was on thursday, (b)(6) 2025.A sable spacer was placed at t12-l1 with supplemental fixation using the revere stabilization system.In the days after surgery, the patient complained of pain.A revision case was performed the following monday, (b)(6) 2025, to remove the implant.The implant was removed without issue, however in the following days after surgery the patient passed away.Imaging of the surgical site was provided.In the imaging, the sable spacer appears to be in an expanded state.The implant appears to be subsided into the t12 vertebra with the distal tip of the implant angled caudally, with implant endplates not parallel to the t12 or l1 vertebral endplates.It appears that the t12 vertebra may have fractured, but this cannot be definitively determined based on the provided imaging.No determinations could be made as to the cause of the reported issue.The following sections have been updated: b4; d6b; g6; h2; h3; h6; h10.
Event or Problem Description
It was reported a was sable spacer was removed from a patient who then later died.

• Brand Name: SABLE
• Common Device Name: SABLE SPACER, 10X26, 9-16MM, 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: 21549849
• Report Number: 3004142400-2025-00069
• Device Sequence Number: 4402184
• Product Code: MAX
• UDI-Device Identifier: 00889095966022
• UDI-Public: 00889095966022
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1172.2113S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/03/2025
• 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: Death
• Patient Sex: Unknown