SI-LOK 139.503SRecalls & reported problems
Globus Medical, Inc. · SI-LOK 10.0mm HA Screw, SL, 35mm · Class 2
- 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 00889095184884), received between Apr 29, 2026 and Apr 29, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THERE HAS BEEN AN INQUIRY FROM A SURGEON WHO IMPLANTED SILOK IN 2024 ABOUT REMOVAL. THE PATIENT BELIEVES THAT THE IMPLANT IS CAUSING PAIN AND WANTS THE IMPLANT REMOVED. THE SURGEON BELIEVES THE JOINT IS FUSED AND THAT REMOVAL MAY NOT BE THE BEST COURSE OF ACTION.
Patient problems: Implant Pain
MAUDE report 25033628 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.