MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SABLE; METALLIC SPINAL INTERBODY FUSION CAGE

Model Number	1172.4210S
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that the surgeon was placing a sable cage at l3-l4.He place the cage and expanded.He didn't like the position and collapsed the cage.When he collapsed the cage and repositioned the cage, the tip of the sable cage fell off in the disc space.We were unable to retrieve the tip, in trying to retrieve the tip the part was pushed anterior.The surgeon is going to monitor this patient.
Additional Manufacturer Narrative
The purpose of this investigation the clinical specialist who reported the event, was contacted over the phone on (b)(6) 2026 where it was confirmed that the spacer body retrieved from the patient was inadvertently discarded after the case.Therefore, the description of the event and the intraoperative images provided.Per the provided information, the nose of the sable cage disassembled after the surgeon over-collapsed the implant while repositioning it.The surgeon then removed the body of the sable cage from the patient.The surgeon attempted to remove the nose from the patient but was unsuccessful.The surgeon decided to leave the nose in the patient and monitor the patient's health post-operatively.As of (b)(6) 2026, no adverse effects to the patient were reported.Over collapsing the implant is a known cause of sable nose disassembly.Within the removal section of the sable technique guide, users are warned not to over-collapse the implant.Therefore, the likely cause of this event is improper handling by the user.The reported failure is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.
Event or Problem Description
It was reported that the surgeon was placing a sable cage at l3-l4.He place the cage and expanded.He didn't like the position and collapsed the cage.When he collapsed the cage and repositioned the cage, the tip of the sable cage fell off in the disc space.We were unable to retrieve the tip, in trying to retrieve the tip the part was pushed anterior.The surgeon is going to monitor this patient.

• Brand Name: SABLE
• Common Device Name: METALLIC SPINAL INTERBODY FUSION CAGE
• 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: 24369766
• Report Number: 3004142400-2026-00019
• Device Sequence Number: 9781822
• Product Code: MAX
• UDI-Device Identifier: 00889095966305
• UDI-Public: 00889095966305
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K192115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1172.4210S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/17/2026
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Race: White