Reliance Spinal Screw System 6-65-050Recalls & reported problems
Vy Spine LLC · 6.5x50mm Screw · 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 00842566105702), received between Oct 18, 2019 and Nov 17, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2021Break; Break
RELIANCE 6.5MMX50MM POLYAXIAL SCREW, TI, IS PART OF THE RMS PEDICLE SCREW SYSTEM. RELIANCE MEDICAL SYSTEMS WAS MADE AWARE OF THE BROKEN SCREW, ON (B)(6) 2021 VIA EMAIL FROM FIELD REP (B)(6). IMPLANTATION OF DEVICE WAS PERFORMED ON (B)(6) 2017 BY DR. (B)(6) AT (B)(6) HOSPITAL. DR. (B)(6) DISCOVERED THE BROKEN SCREW DURING REVISION ON (B)(6) 2021. PHYSICIAN REPORTED THERE WAS NO HARM OR INJURY TO THE PATIENT. SCREW HEAD WAS REMOVED AND THE EMBEDDED SCREW SHAFT WAS LEFT IN THE BONE PER PHYSICIAN. IT IS UNKNOWN WHEN OR HOW THE SCREW BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12829163 ↗MalfunctionOct 18, 2019Fracture; Fracture
RELIANCE 6.5MM X 50MM POLYAXIAL SCREW, TI, IS PART OF THE RMS PEDICLE SCREW SYSTEM. RELIANCE MEDICAL SYSTEMS WAS MADE AWARE OF THE TWO BROKEN SCREWS, SEPTEMBER 24TH, 2019 VIA EMAIL FROM PHYSICIAN. IMPLANTATION OF DEVICES WAS PERFORMED (B)(6) 2018 BY DR. (B)(6) AT (B)(6) MEDICAL CENTER. DR (B)(6) DISCOVERED THE BROKEN SCREWS DURING SCREW REMOVAL ON (B)(6) 2019. PHYSICIAN REPORTED THERE WAS NO INJURY TO THE PATIENT. SCREW HEADS WERE REMOVED AND SENT TO PATHOLOGY AND THE EMBEDDED SCREW SHAFT WAS LEFT IN THE BONE PER PHYSICIAN. IT IS UNKNOWN WHEN OR HOW THE SCREWS BROKE.
Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient
MAUDE report 9210041 ↗
Other Orthosis, Spinal Pedicle Fixation devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 reports
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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