ReLine 16191111Recalls & reported problems
Nuvasive, Inc. · RELINE MAS MOD, Reduction Extension · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887517655806), received between Feb 12, 2020 and Dec 1, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 16, 2026.
Most reported problems
Device problems
- Break3
- Misassembled During Installation2
- Migration1
- Separation Problem1
Patient problems
- Pain4
- No Consequences Or Impact To Patient2
- Failure of Implant1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2022Separation Problem; Separation Problem
ON (B)(6) 2022 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM L4 TO L5 AND THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON (B)(6) 2022 IT WAS REPORTED THE PATIENT ROLLED OUT OF BED. DURING A FOLLOW UP APPOINTMENT ON (B)(6) 2022 IT WAS DISCOVERED VIA RADIOGRAPH THAT A TULIP HEAD HAD DISASSOCIATED FROM THE ATTACHED SCREW SHANK. THE PATIENT WAS HAVING TO ADVERSE CONSEQUENCES AS A CONSEQUENCE OF THE DISASSOCIATION. ON NOVEMBER 12 A REVISION OCCURRED WHERE THE DEVICE WAS REPLACED. THE PATIENT IS DOING WELL POST REVISION.
Patient problems: Pain
MAUDE report 15900782 ↗MalfunctionJul 1, 2020Migration; Migration
ON (B)(6) 2019, PATIENT UNDERWENT A SPINAL PROCEDURE AT L4-S1 LEVELS. POSTOPERATIVELY, IT WAS DISCOVERED THE RELINE MAS MOD, REDUCTION EXTENSION TULIP HEADS BACKED OUT. NO REVISION PROCEDURE HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 10221856 ↗MalfunctionFeb 24, 2020Break; Break
INFORMATION RECEIVED STATED A SURGICAL CASE WAS PERFORMED A FEW MONTHS BACK WITH RELINE MAS REDUCTION WHERE ONE OF THE TABS DID NOT BREAK ALL THE WAY OFF. PATIENT UNDERWENT A REVISION PROCEDURE.
Patient problems: Pain
MAUDE report 9747532 ↗MalfunctionFeb 12, 2020Break; Misassembled During Installation; Break; Misassembled During Installation
ON AN UNKNOWN DATE A PATIENT UNDERWENT A POSTERIOR PROCEDURE AT L4-S1 WITHOUT ANY REPORTED INCIDENTS. DURING A POSTOPERATIVE VISIT THE REDUCTION EXTENSION TABS WERE DISCOVERED STILL IN-SITU. NO REVISION PROCEDURE IS CURRENTLY PLANNED.
Patient problems: No Consequences Or Impact To Patient; Pain
MAUDE report 9703383 ↗MalfunctionFeb 12, 2020Break; Misassembled During Installation; Break; Misassembled During Installation
ON AN UNKNOWN DATE A PATIENT UNDERWENT A POSTERIOR PROCEDURE AT L4-S1 WITHOUT ANY REPORTED INCIDENTS. DURING A POSTOPERATIVE VISIT THE REDUCTION EXTENSION TABS WERE DISCOVERED STILL IN-SITU. NO REVISION PROCEDURE IS CURRENTLY PLANNED.
Patient problems: No Consequences Or Impact To Patient; Pain
MAUDE report 9703324 ↗
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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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