Reliance Spinal Screw System 3-00-001Recalls & reported problems
Vy Spine LLC · Set Screw (5.5mm) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842566102206), received between Jun 11, 2022 and Jun 25, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 18, 2026.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
RELIANCE SET SCREW, TI, IS PART OF THE RMS SPINAL SCREW SYSTEM. RELIANCE MEDICAL SYSTEMS WAS MADE AWARE OF THE LOOSE SET SCREW, (B)(6) 2022 BY FIELD REP (B)(4). IMPLANTATION OF DEVICE WAS PERFORMED (B)(6) 2021 BY DR. (B)(6) AT (B)(6) REGIONAL. DR (B)(6). DISCOVERED THE LOOSE SET SCREWS DURING A REVISION PROCEDURE FOR AN ADJACENT LEVEL ON (B)(6) 2022. IT IS UNKNOWN WHEN THE SET SCREWS CAME LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14811991 ↗MalfunctionJun 11, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
RELIANCE SET SCREW, TI, IS PART OF THE RMS SPINAL SCREW SYSTEM. RELIANCE MEDICAL SYSTEMS WAS MADE AWARE OF THE LOOSE SET SCREW, (B)(6) 2022 BY FIELD REP JOHN HUNT. IMPLANTATION OF DEVICE WAS PERFORMED (B)(6) 2022 BY DR. ESCE. DR ESCE DISCOVERED A SET SCREW HAD COME OFF A PEDICLE SCREW DURING A POST OP. IT IS UNKNOWN WHEN OR HOW THE SET SCREW CAME OFF THE PEDICLE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14671824 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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