ReLine 14514530Recalls & reported problems
Nuvasive, Inc. · RSS Screw, 4.5x30mm Polyaxial 2S · Class 2 · Implant
Data updated Oct 13, 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 00887517767653), received between Mar 7, 2019 and Jun 30, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Unintended Movement1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE. SUBSEQUENTLY, ON AN UNKNOWN DATE, IT WAS IDENTIFIED THAT THE POLYAXIAL TULIP FEATURE OF THE PEDICLE SCREW SEPARATED FROM THE SCREW SHANK POST OPERATIVELY. THERE WERE NO REPORTS OF ANY FALL OR OTHER TRAUMATIC EVENT EXPERIENCED BY THE PATIENT THAT MAY HAVE ATTRIBUTED TO THE EVENT. THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY SIX (6) MONTHS LATER TO REVISE THE IMPLANT. NO FURTHER PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14881480 ↗MalfunctionMar 7, 2019Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE. DURING A REVISION, THE SURGEON NOTICED THAT ONE SCREW HAD PULLED OUT IN THE LUMBAR REGION (L4- RIGHT). THE PULLED OUT SCREW WAS REPLACED WITH NO REPORTED ISSUE. AS PER REPORTER, THE PATIENT IS CURRENTLY DOING WELL POST-REVISION. THE REASON FOR THE REVISION WAS NOT CONFIRMED.
Patient problems: Failure of Implant
MAUDE report 8401953 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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