ReLine 10000800Recalls & reported problems
Nuvasive, Inc. · RELINE MAS Screwdriver, Poly Cann · Class 2
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 00887517561084), received between Feb 21, 2023 and Aug 14, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR PROCEDURE FROM L5 TO S. DURING THE PROCEDURE, WHILE THE SURGEON WAS INSERTING THE PEDICLE SCREW INTO THE LEFT S1, THE TIP OF THE DRIVER FRACTURED OFF WITHIN THE SCREW. THE TIP WAS LEFT IN-SITU, EMBEDDED IN THE SCREW. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 19987081 ↗MalfunctionFeb 21, 2023Fracture; Fracture
ON (B)(6) 2023 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM L2 TO SAI. WHILE INSERTING A PEDICLE SCREW AT L4 THE TIP OF THE DRIVER FRACTURED OFF IN THE ENGAGED SCREW HEAD. THE BROKEN PIECE COULD NOT BE RETRIEVED AND WAS LEFT IN-SITU. ANOTHER SCREWDRIVER WAS USED, AND THE FIXATION PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 16409644 ↗
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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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