ReLine 10000751Recalls & reported problems
Nuvasive, Inc. · RELINE-O Final Lock Screw Driver · Class 1
All models of ReLine (129)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nuvasive ReLine-O Final Lock Screw Driver is a hand tool used to tighten screws during spinal surgery. The 71 reports mostly describe the tip snapping off during final tightening, leaving a broken metal fragment stuck inside the screw or its cap that surgeons often could not retrieve. No deaths and no injuries were reported. There are no recalls naming this device, and reports rose from 6 in the earlier 12-month period to 15 in the most recent one.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00887517513724), received between Jul 13, 2022 and Jun 5, 2026 — classified as 71 malfunctions.
The most frequently reported specific device problem is “Fracture” (71 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
- Fracture71
Patient problems
- Foreign Body In Patient67
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2026Fracture
THE TIP OF THE LOCK SCREW DRIVER BROKE OFF IN THE LOCK SCREW CAP DURING FINAL TIGHTENING. NO ADVERSE EFFECT TO THE PATIENT. THE SURGEON WAS UNABLE TO RETRIEVE THE PIECE, AS IT WAS SHEARED OFF FLUSH WITH THE LOCKING CAP.
Patient problems: Foreign Body In Patient
MAUDE report 25411537 ↗MalfunctionJun 5, 2026Fracture
IT WAS REPORTED THAT A RELINE-O FINAL LOCK SCREWDRIVER SHAFT BROKE DURING FINAL TIGHTENING, AND THE TIP WAS COLD WELDED INTO THE SCREW.
Patient problems: Foreign Body In Patient
MAUDE report 25410830 ↗MalfunctionMay 18, 2026Fracture
IT WAS REPORTED THAT DURING SPINAL SURGERY, THE TIP OF T-HANDLE NUVASIVE SCREWDRIVER BROKE OFF WITHIN THE SET SCREW CAP. THE PORTION OF THE SCREWDRIVER TIP WAS FIRMLY POSITIONED IN THE SET SCREW. ATTEMPTS WERE MADE TO REMOVE IT, BUT THE COLD WELDING DISALLOWED EXTRACTION AND RISKS OF FURTHER ATTEMPTS TO EXTRACT WERE DETERMINED TO BE GREATER RISK THAN LEAVING IN PLACE. NO HARM NOTED TO PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 25205427 ↗MalfunctionMar 13, 2026Fracture
IT WAS REPORTED THAT THE DISTAL STAR TIP OF RELINE FINAL LOCK SCREW DRIVER BROKE OFF IN SET CAP DURING FINAL TIGHTEN. BROKEN PIECE WAS NOT ABLE TO BE RETRIEVED FROM PATIENT. PATIENT WAS NOT HARMED AND WE WERE ABLE TO COMPLETE CASE.
Patient problems: Foreign Body In Patient
MAUDE report 24599005 ↗MalfunctionJan 22, 2026Fracture
IT WAS REPORTED THAT THE TIP OF A RELINE-O FINAL LOCK SCREW DRIVER BROKE OFF IN THE LOCKSCREW DURING A CASE. THE LOCKSCREW REMAINED IMPLANTED IN PATIENT, WITH THE BROKEN PIECE OF SCREW INSIDE. THERE WERE NO CONSEQUENCES FOR THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 24148360 ↗MalfunctionJan 21, 2026Fracture
IT WAS REPORTED THAT THE TIP OF THE RELINE-O FINAL LOCK SCREW DRIVER THAT SITS IN CAP BROKE OFF INSIDE OF LOCKING CAP.
Patient problems: Foreign Body In Patient
MAUDE report 24135943 ↗MalfunctionJan 20, 2026Fracture
IT WAS REPORTED THAT THE TIP OF DRIVER BROKE OFF IN SET SCREW AND IS PERMANENTLY STUCK IN PLACE. THE PART WAS NOT RETRIEVED AND NOTHING WAS PLACED TO PREVENT MIGRATION IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24118039 ↗MalfunctionJan 7, 2026Fracture
IT WAS REPORTED THAT THE TIP OF THE RELINE O FINAL LOCK SCREW DRIVER BROKE DURING THE CLOSING PROCESS WITH THE TORQUE. TORQUE WAS TESTED AND FAILED. THE TIP STAYED INSIDE THE LOCK SCREW, NO OPTION TO REMOVE IT, BUT NO IMPACT TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23993957 ↗MalfunctionDec 31, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE RELINE FINAL DRIVER BROKE OFF WHEN THE SURGEON TRIED THE FINAL TIGHTENING OF THE LOCKING SCREW TO CONNECT THE SPINAL ROD TO THE SPINAL SCREW. AFTER REMOVING THE FRAGMENTS AND TIGHTENING WITH ANOTHER DRIVER, THE SURGERY WAS COMPLETED. NO OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23935118 ↗MalfunctionDec 22, 2025Fracture; Fracture
THE TIP BROKE WHILE THE CLOSING PROCESS WITH THE TORQUE. TORQUE WAS TESTED AND TEST WAS SUCCESSFUL. THE TIP STAYED INSIDE THE LOCK SCREW, NO OPTION TO REMOVE IT, BUT NO IMPACT TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23871301 ↗MalfunctionDec 17, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF IN THE LOCKSCREW. THE LOCKSCREW REMAINED IMPLANTED IN THE PATIENT. THIS EVENT OCCURRED IN ITALY.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23827170 ↗MalfunctionDec 11, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF IN THE LOCKSCREW. THE LOCKSCREW REMAINED IMPLANTED IN THE PATIENT. THIS EVENT OCCURRED IN ITALY.
Patient problems: Foreign Body In Patient
MAUDE report 23779269 ↗MalfunctionDec 11, 2025Fracture; Fracture
THE TIP OF THE SCREWDRIVER BROKE OFF IN THE LOCKSCREW. THE LOCKSCREW REMAINED IMPLANTED IN THE PATIENT. THERE WAS NO ADVERSE EFFECT TO PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23779018 ↗MalfunctionDec 11, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF IN THE LOCKSCREW. THE LOCKSCREW REMAINED IMPLANTED IN THE PATIENT. NO ADVERSE EFFECT TO PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23778891 ↗MalfunctionNov 4, 2025Fracture; Fracture
THE TIP BROKE DURING THE CLOSING PROCESS, AND THEY WERE NOT ABLE TO REMOVE IT FROM THE LOCK SCREW. NO PATIENT ADVERSE EFFECT. THIS EVENT OCCURRED IN SPAIN.
Patient problems: Foreign Body In Patient
MAUDE report 23464227 ↗MalfunctionOct 15, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE RELINE O FINAL LOCK SCREWDRIVER BROKE AND REMAINED IN THE IMPLANTED SCREW. THIS EVENT OCCURRED IN SPAIN.
Patient problems: Foreign Body In Patient
MAUDE report 23293187 ↗MalfunctionMay 8, 2025Fracture; Fracture
DURING FINAL TIGHTENING PROCESS, DRIVER TIP SHEARED OFF INSIDE LOCK SCREW CAP. PIECE WAS NOT RETRIEVABLE FROM PATIENT, WOULD REQUIRE DRILLING OUT OF THE LOCK SCREW AND WOULD COMPROMISE THE PEDICLE SCREW LOCK SCREW INTERFACE. CONFIRMED THAT SETSCREW WAS IN LINE WITH THE TULIP HEAD FOR FINAL TIGHTENING.
Patient problems: Foreign Body In Patient
MAUDE report 21990506 ↗MalfunctionFeb 7, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, WHILE THE SURGEON WAS FINAL TIGHTENING, THE TIP OF THE FINAL LOCK SCREW DRIVER FRACTURED OFF WITHIN THE LOCK SCREW ON L5. THE TIP WAS LEFT IN-SITU, EMBEDDED IN THE LOCK SCREW. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 21334710 ↗MalfunctionJan 10, 2025Fracture; Fracture
DURING A LATERAL SPINAL PROCEDURE FROM L3 TO L5, WHEN FINAL TIGHTENING THE DISTAL TIP OF THE DRIVER FRACTURED OFF IN THE RIGHT L5 LOCK SCREW AND COULD NOT BE RETRIEVED. THE FRACTURED PORTION WAS RETAINED IN THE IMPLANT SO THE SURGEON OPTED TO LEAVE THE PORTION IN SITU. NO FURTHER PATIENT IMPACT WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 21131665 ↗MalfunctionJan 10, 2025Fracture; Fracture
DURING AN OBLIQUE LATERAL LUMBAR INTERBODY FUSION PROCEDURE FROM L2 TO L4 WITH A TRANSFORAMINAL LUMBAR INTERBODY FUSION FROM L4 TO L5, WHILE FINAL TIGHTENING, THE DISTAL TIP FRACTURED OFF IN THE RIGHT L2 PEDICLE SCREW LOCK SCREW AND COULD NOT BE RETRIEVED FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 21130411 ↗MalfunctionNov 11, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR LUMBAR PROCEDURE. DURING THE PROCEDURE, WHILE THE SURGEON WAS FINAL TIGHTENING, THE TIP OF THE FINAL LOCK SCREW DRIVER FRACTURED OFF WITHIN THE LOCK SCREW. THE TIP WAS LEFT IN-SITU, EMBEDDED IN THE LOCK SCREW. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 20657358 ↗MalfunctionOct 29, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, WHILE THE SURGEON WAS FINAL TIGHTENING, THE TIP OF THE FINAL LOCK SCREW DRIVER FRACTURED OFF WITHIN THE LOCK SCREW. THE TIP WAS LEFT IN-SITU, EMBEDDED IN THE LOCK SCREW. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20559593 ↗MalfunctionOct 22, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, WHILE THE SURGEON WAS FINAL TIGHTENING, THE TIP OF THE FINAL LOCK SCREW DRIVER FRACTURED OFF WITHIN THE LOCK SCREW. THE TIP WAS LEFT IN-SITU, EMBEDDED IN THE LOCK SCREW. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 20510319 ↗MalfunctionOct 4, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN THORACIC PROCEDURE. DURING THE PROCEDURE, WHILE THE SURGEON WAS FINAL TIGHTENING, THE TIP OF THE FINAL LOCK SCREWDRIVER FRACTURED OFF WITHIN THE LOCK SCREW. THE TIP WAS LEFT IN-SITU, EMBEDDED IN THE LOCK SCREW. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 20370985 ↗MalfunctionAug 23, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE. DURING THE PROCEDURE, WHILE THE SURGEON WAS FINAL TIGHTENING, THE TIP OF THE FINAL LOCK SCREW DRIVER FRACTURED OFF WITHIN THE LOCK SCREW. THE TIP WAS LEFT IN-SITU, EMBEDDED IN THE LOCK SCREW. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 20052488 ↗
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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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