ReLine 11102255Recalls & reported problems
Nuvasive, Inc. · RELINE-O Conn, 5-6/5-6mm O-H Med · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 16, 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 00887517596185), received between Oct 25, 2021 and Oct 11, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Loose or Intermittent Connection1
- Misassembled During Installation1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2022Loose or Intermittent Connection; Detachment of Device or Device Component; Misassembled During Installation; Loose or Intermittent Connection; Detachment of Device or Device Component; Misassembled During Installation
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE. SUBSEQUENTLY, DURING A ROUTINE FOLLOW UP APPROXIMATELY THREE (3) MONTHS LATER, IT WAS IDENTIFIED THAT THE LOCK SCREW OF THE ROD-TO-ROD CONNECTOR AT L4/L5 HAD LOOSENED. THE PATIENT NOTED EXPERIENCING SYMPTOMS OF PAIN IN ADDITION TO THE FEELING OF LOOSE COMPONENTS. A REVISION PROCEDURE WAS PERFORMED APPROXIMATELY SIX (6) MONTHS AFTER THE INITIAL PROCEDURE TO REMOVE AND REPLACE THE CONNECTOR AND LOCK SCREW. NO FURTHER PATIENT IMPACT WAS REPORTED. THE PATIENT IS REPORTED TO BE DOING WELL POST-REVISION PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 2 OF 2.
Patient problems: Pain
MAUDE report 15577425 ↗MalfunctionOct 25, 2021Separation Problem; Separation Problem
ON (B)(6) 2021 A PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE FROM T12 TO L2. DURING A POST-OP FOLLOW UP ON AND UNKNOWN DATE IT WAS DISCOVERED VIA RADIOGRAPH THAT THE ROD SLIPPED AND DISPLACED FROM THE CONNECTOR. ON (B)(6) 2021 A REVISION OCCURRED WERE BOTH IMPLANTED CONNECTORS AND THE RODS WERE REPLACED. THE PATIENT IS RECOVERING WELL POST REVISION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12691667 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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