ION 55 Facet Implant - Sterile TI-K-55Recalls & reported problems
Surgentec, LLC · Class U
Data updated Oct 18, 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 00810131881801), received between Jul 29, 2026 and Jul 29, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Use of Device Problem
It appears that upon disengagement of the driver from the screw all seemed well. According to the physician, upon removing the cannula/drill-guide, the screw got sucked into the canal beneath the lamina. The physician had to do an emergent laminectomy at C/3 to remove the screw from the canal. PT had issues, CT was ordered. All looked good and the patient is slowly improving. No SurGenTec devices malfunctioned during this procedure.
Patient problems: Foreign Body In Patient
MAUDE report 50065953 ↗
Other System, Facet Screw Spinal Device devices
- ZYFUSE 147.541SGlobus Medical, Inc. · SYSTEM, FACET SCREW SPINAL DEVICE1 report
- Zyfix Spinal Facet Screw System X076-0020Xtant Medical Holdings, Inc. · SYSTEM, FACET SCREW SPINAL DEVICE1 report
- VIPER 175710130Medos International Sàrl · SYSTEM, FACET SCREW SPINAL DEVICE1 report
- 4.5mm BONE-LOK PLS Implant LSW-45-4555Interventional Spine, Inc · System, Facet Screw Spinal Device1 report
- CORRIDOR 148.540Globus Medical, Inc. · SYSTEM, FACET SCREW SPINAL DEVICE1 report
- VIPER 175710535Medos International Sàrl · SYSTEM, FACET SCREW SPINAL DEVICE1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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