N/A 639.650Recalls & reported problems
Globus Medical, Inc. · SIJ 4mm Hex Driver · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00849044075007), received between Nov 22, 2021 and Nov 19, 2025 — classified as 4 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
- Break1
- Human-Device Interface Problem1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Spinal Column Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF DRIVER BROKE OFF IN SURGERY. THE SURGEON WAS ON THE LAST SCREW AND FELT IT SNAP, DIDN'T INSPECT IT AND DIDN'T NOTICE ANYTHING IN THE PATIENT WHEN TAKING FINAL XRAYS. AT POST OP VISIT AND XRAYS WEEKS LATER, NOTICED THE TIP HAD DISLODGED FROM THE SCREW HEAD AND WAS VISIBLE ON XRAY. IT IS CAUSING NO ISSUES AND DR DOESN'T PLAN ON DOING ANY REMOVAL AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23595861 ↗MalfunctionOct 2, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY THE TIP OF THE DRIVER WAS BROKEN AND LEFT IN THE PATIENT POST OPERATIVELY. THIS EVENT OCCURRED IN THE UNITED KINGDOM.
Patient problems: Insufficient Information
MAUDE report 20354224 ↗MalfunctionMar 4, 2024Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT WHEN THE SURGEON WAS PLACING A 12X40MM SI-LOK SCREW, THE THREADS ON THE OUTER SLEEVE OF THE DRIVER BROKE OFF IN THE SCREW HEAD. THE SURGEON WAS UNABLE TO REMOVE THE THREADS AND LEFT THEM IN THE SCREW HEAD.
Patient problems: Spinal Column Injury
MAUDE report 18831628 ↗MalfunctionNov 22, 2021Break
IT WAS REPORTED THAT THE THREADED TIP OF A SI-LOK DRIVER WAS LEFT IN THE PATIENT AFTER IT BROKE DURING SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 12855881 ↗
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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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