ReLine 11103055Recalls & reported problems
Nuvasive, Inc. · RELINE-O Conn, 5-6/5-6mm Rotating O-O · 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 00887517596222), received between Jun 5, 2017 and Nov 25, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Separation 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 16, 2026.
Most reported problems
Device problems
- Separation Problem1
- Unintended Movement1
Patient problems
- Failure of Implant1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2020Separation Problem; Separation Problem
THE PATIENT UNDERWENT A SPINAL PROCEDURE WITH RELINE PRODUCTS ON UNKNOWN DATE. IN THE SURGERY, THE PHYSICIAN INSTALLED RODS ON THE L3/4 AND ATTACHED O-O ROTATING CONNECTORS ON THE RODS. AFTER THAT, THE PHYSICIAN INSTALLED ANOTHER RODS ON THE O-O ROTATING CONNECTORS AND JOINTED TO L4/SAI WITH ITS RODS. ON (B)(6) 2020, DUE TO A PSEUDARTHROSIS (NONUNION), THE PATIENT UNDERWENT A REVISION SURGERY IN ORDER TO RE-FIX FROM L3 TO SAI WITH SINGLE RODS. INTRAOPERATIVELY, WHEN THE PHYSICIAN TRIED TO REMOVE THE O-O ROTATING CONNECTORS OF L3/4, HE NOTICED THAT THE O-O ROTATING CONNECTOR ON THE LEFT SIDE FRACTURED. HE REMOVED THE BROKEN PARTS, HOWEVER, HE WAS NOT ABLE TO FIND ONE BROKEN PART. HE DECIDED TO COMPLETE THE OPERATION WITHOUT REMOVING IT.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 10900596 ↗MalfunctionJun 5, 2017Unintended Movement; Unintended Movement
ON (B)(6) 2017 A PATIENT UNDERWENT A MULTI-LEVEL INTERBODY REPLACEMENT PROCEDURE WITH ADDITIONAL POSTERIOR FIXATION FROM T11 TO S1 WITHOUT ISSUE. DURING A LATER FOLLOW UP VISIT RADIOGRAPHS CONFIRMED TWO LOCK SCREWS BACKING OUT ON THE RIGHT SIDE CONNECTORS. ON (B)(6) 2017 A REVISION TOOK PLACE REPLACING CONNECTORS AND LOCK SCREWS WITHOUT ISSUE. NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 6610960 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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