N/A 6134.0185Recalls & reported problems
Globus Medical, Inc. · Locking Cap Driver · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889095178289), received between Dec 15, 2022 and May 19, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
- Material Fragmentation2
- Break1
- Insufficient Device Problem Information1
Patient problems
- Foreign Body In Patient3
- Insufficient Information2
- Spinal Column Injury1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Fracture
IT WAS REPORTED THAT THE ASSISTANT TO THE SURGEON WAS LOCKING DOWN THE LOCKING CAPS OVER ZEALOUSLY AND SHEARED THE TIP OF THE DRIVER OFF IN THE BOTTOM RIGHT SCREW. FOLLOWING TRYING TO RETRIEVE THE TIP, IT WAS NOTED IT HAD COLD WIELDED INTO THE LOCKING CAPS AND COULD NOT BE RETRIEVED. THE SURGEON MADE THE DECISION NOT TO PERSUE ANY FURTHER AND TO LEAVE THE TIP SAFELY COLD WIELDED IN THE LOCKING CAPS.
Patient problems: Foreign Body In Patient
MAUDE report 25221673 ↗MalfunctionFeb 17, 2026Fracture
IT WAS REPORTED THAT THE DRIVER TIPS SHEARED OFF WHEN ADVANCING SET CAPS.
Patient problems: Foreign Body In Patient
MAUDE report 24369764 ↗MalfunctionApr 4, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A CASE THE TIP OF THE LOCKING CAP DRIVER BROKE OFF AND WAS RETAINED IN THE PATIENT POST OPERATIVELY.
Patient problems: Spinal Column Injury
MAUDE report 19043339 ↗MalfunctionMar 5, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING SURGERY THE TIP OF THE CREO MIS LOCKING CAP DRIVER WAS BROKEN AND LEFT IN THE PATIENT. THIS EVENT OCCURRED IN AUSTRALIA.
Patient problems: Insufficient Information
MAUDE report 18834287 ↗MalfunctionMar 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
DURING SURGERY, THE LOCKING CAP DRIVER TIP SHEARED OFF AND WAS LEFT IN THE SET SCREW.
Patient problems: Insufficient Information
MAUDE report 18822388 ↗MalfunctionDec 15, 2022Break
THE TIP OF THE INSTRUMENT BROKE DURING TEMPORARY FIXATION OF A LOCKING CAP AND REMAINS IN THE PATIENT. THIS EVENT OCCURRED IN GERMANY.
Patient problems: Foreign Body In Patient
MAUDE report 15989223 ↗
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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.
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