ReLine 10001139Recalls & reported problems
Nuvasive, Inc. · NAV.S 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517955432), received between Jun 30, 2022 and Jun 5, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
Patient problems
- Foreign Body In Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2023Fracture; Fracture
DURING A SPINAL PROCEDURE AT L3/PELVIS, THE TIP OF THE DRIVER WAS REPORTED AS FRACTURED OFF CLEAN AND LEFT IN-SITU IN THE LEFT ILIAC SCREW. NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 17066230 ↗MalfunctionJan 9, 2023Fracture; Fracture
ON (B)(6) 2022 A PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE AT L4/L5. DURING THE PROCEDURE, WHILE PLACING THE SCREW THE DISTAL TIP OF THE SCREW DRIVER FRACTURED OFF INTO THE SHANK AND WAS LEFT IN-SITU. NO ADDITIONAL ISSUES REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 16127656 ↗MalfunctionNov 30, 2022Fracture; Fracture
ON (B)(6) 2022 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. DURING THE PROCEDURE TWO SEPARATE DRIVER TIPS FRACTURED OFF INTO ENGAGED SCREWS BUT ONLY ONE WAS ABLE TO BE RETRIEVED FROM THE PATIENT WHILE THE OTHER WAS LEFT IN SITU. IT WAS REPORTED THAT TORQUE HANDLES WERE NOT BEING USED DURING THE FAILURE. THE SURGERY WAS COMPLETED WITHOUT ISSUE OR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 15886786 ↗MalfunctionJun 30, 2022Fracture; Fracture
ON (B)(6) 2022 DURING A SPINAL PROCEDURE THE TIP OF THE SCREWDRIVER WAS BROKEN OFF AND LEFT IN THE SCREW SHANK BECAUSE IT COULD NOT BE RECOVERED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 14881545 ↗
Other Orthopedic stereotaxic instrument devices
- REAL INTELLIGENCE ROB10024Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall924 reports
- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
- RESTORIS, RIO 212760Mako Surgical Corp. · Orthopedic stereotaxic instrument605 reports
- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 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.
How reports and recalls are matched · Editorial policy · Report an error on this page