N/A 6067.0060Recalls & reported problems
Globus Medical, Inc. · Self-retaining Driver Shaft, 1/4" Quick-connect · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889095167979), received between Mar 1, 2024 and Jun 17, 2026 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Insufficient Device Problem Information1
- Mechanical Problem1
- Use of Device Problem1
Patient problems
- Insufficient Information3
- Foreign Body In Patient2
- Spinal Column Injury1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2026Fracture
IT WAS REPORTED THAT A CREO LOCKING CAP POPPED OUT ON (B)(6) 2026, A YEAR AFTER SURGERY WAS COMPLETED. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2025.
Patient problems: Foreign Body In Patient
MAUDE report 25535620 ↗MalfunctionMay 5, 2026Fracture
IT WAS REPORTED THAT THE DISTAL TIP SHEARED OFF IN LOCKING CAP DUE TO TORQUE NOT RELEASING. THE TIP WAS LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 25082103 ↗InjuryAug 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A POTENTIAL PATIENT ADVERSE EFFECT HAD OCCURRED INVOLVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 22689826 ↗MalfunctionOct 25, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF INSTRUMENT SHEERED OFF WHILE REMOVING EXISTING HARDWARE.
Patient problems: Insufficient Information
MAUDE report 20534804 ↗MalfunctionMar 4, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT WHEN BACKING OUT THE SCREW AT L4, THE DRIVER TIP BROKE OFF WITHIN THE SCREW HEAD. THE TIP WAS NOT ABLE TO BE RETRIEVED.
Patient problems: Spinal Column Injury
MAUDE report 18829843 ↗MalfunctionMar 4, 2024Fracture; Fracture
IT WAS REPORTED BY A GLOBUS BELGIUM SALES REPRESENTATIVE, THE TIP OF THE SELF-RETAINING DRIVER SHAFT BROKE OFF WITHIN THE SET SCREW. THE INSTRUMENT TIP WAS UNABLE TO BE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 18825614 ↗MalfunctionMar 1, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING SURGERY THE TIP OF THE CREO SELF-RETAINING DRIVER SHAFT WAS BROKEN AND LEFT IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 18821980 ↗
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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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