SABLE 1172.2021SRecalls & reported problems
Globus Medical, Inc. · SABLE Spacer, 10x22, 7-13mm, 15° · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889095965889), received between Oct 22, 2025 and Oct 22, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Migration1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 22, 2025Migration; Migration
IT WAS REPORTED THAT THE SURGEON, DR. (B)(6), WAS ATTEMPTING TO PLACE BILATERAL CAGES INTO A SINGLE DISC SPACE. HE PLACED AND OPENED THE FIRST CAGE SUCCESSFULLY. WHEN HE IMPACTED THE SECOND CAGE INTO THE DISC SPACE, IT APPEARED THAT HE MAY HAVE MADE CONTACT WITH THE FIRST CAGE THAT WAS ALREADY IMPLANTED. HE STOPPED TO TAKE AN X-RAY AND WAS ABLE TO CONFIRM THAT HE HAD MADE CONTACT WITH THE FIRST CAGE AND IT HAD MIGRATED ANTERIORLY PAST THE ANTERIOR BORDER OF THE DISC SPACE. HE THEN PULLED THE SECOND CAGE OUT AND ATTEMPTED TO RETRIEVE THE FIRST CAGE. AFTER MULTIPLE ATTEMPTS TO ENGAGE THE FIRST CAGE WITH THE INSERTER AND HOSPITAL INSTRUMENTS HE LANDED UP INADVERTENTLY MOVING THE CAGE OUTSIDE OF THE DISC SPACE. HE PROCEEDED WITH THE PROCEDURE AND PLACED A UNILATERAL CAGE AT THAT LEVEL.
Patient problems: Insufficient Information
MAUDE report 23360336 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page