ReLine 10000750Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00887517513717), received between May 31, 2022 and May 8, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Fracture

  IT WAS REPORTED THAT THE TIP OF THE RELINE MAS FINAL LOCK SCREW DRIVER WAS FRACTURED WHEN THE SURGEON USED IT FOR FINAL TIGHTENING. THE SURGEON COULD NOT REMOVE THE FRAGMENT FROM THE LOCK SCREW AND REMAINS IN THE BODY. THERE WAS NO OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25126694 ↗
• MalfunctionAug 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE END OF THE RELINE DRIVER BROKE OFF DURING SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22882723 ↗
• MalfunctionApr 24, 2025Fracture; Fracture

  TIP OF THIS INSTRUMENT BROKE OFF INTO THE LOCK SCREW AND COLD WELDED ITSELF INTO THE LOCK SCREW AND LEFT IN-SITU.

  Patient problems: Foreign Body In Patient

  MAUDE report 21905875 ↗
• MalfunctionDec 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION PROCEDURE FROM L3 TO L5, WHILE THE SURGEON WAS FINAL TIGHTENING THE LOCK SCREW AT THE RIGHT L4 LEVEL, 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 21048519 ↗
• MalfunctionSep 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT A DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION, 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 20311736 ↗
• MalfunctionAug 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FROM L3 TO S1. DURING THE PROCEDURE, WHILE THE SURGEON WAS FINAL TIGHTENING THE LOCK SCREW ON THE LEFT S1, 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 20034201 ↗
• MalfunctionFeb 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DRIVER TIP FRACTURED OFF. THE FRACTURED PORTION COULD NOT BE RETRIEVED AND THEREFORE REMAINS IN THE PATIENT. THERE HAS BEEN NO REPORT OF ADVERSE PATIENT IMPACT AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18628589 ↗
• MalfunctionJun 16, 2023Fracture; Fracture

  IT WAS REPORTED THE DISTAL TIP OF THE DRIVER FRACTURED OFF WHILE FINAL TIGHTENING THE LOCK SCREW DURING A POSTERIOR PROCEDURE; THE FRACTURED TIP WAS NOT RECOVERED AND REMAINS LODGED IN THE LOCK SCREW. THERE WAS NO REPORTED ADVERSE PATIENT OR PROCEDURE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17148324 ↗
• MalfunctionMay 25, 2023Fracture; Fracture

  DURING A PROCEDURE, THE DRIVER TIP FRACTURED OFF WHILE FINAL TIGHTENING THE LOCK SCREW. THE FRACTURED PORTION COULD NOT BE RETRIEVED AND THEREFORE REMAINS IN THE PATIENT; HOWEVER, THE FRACTURED PORTION WAS REPORTED TO BE LODGED WITHIN THE LOCK SCREW. THERE WAS NO DELAY IN SURGERY AND THERE HAS BEEN NO REPORT OF ADVERSE PATIENT IMPACT AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17007269 ↗
• MalfunctionOct 21, 2022Fracture; Fracture

  DURING A POSTERIOR FIXATION FROM LEVELS L2 TO L5 WHILE FINAL TIGHTENING THE LEFT L2 LOCK SCREW, THE TIP OF THE FINAL LOCK SCREW DRIVER FRACTURED. THE FRACTURED PIECE COULD NOT BE RETRIEVED AND AS A RESULT WAS RETAINED IN THE PATIENT. NO INJURY AND NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15655872 ↗
• MalfunctionSep 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MINIMALLY INVASIVE POSTERIOR FIXATION PROCEDURE. DURING THE PROCEDURE, THE DISTAL TORX FEATURE OF THE FINAL TIGHTENING DRIVER FRACTURED OFF INTO THE LOCK SCREW. AFTER APPROXIMATELY 20-30 MINUTES WERE USED IN AN EFFORT TO RETRIEVE THE FRACTURED PIECE, IT WAS DETERMINED TO BE CAPTURED WITHIN THE LOCK SCREW AND UNABLE TO BE RETRIEVED. AS A RESULT, THE TIP WAS RETAINED IN THE PATIENT. NO INJURY AND NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15341267 ↗
• MalfunctionJun 2, 2022Fracture; Fracture

  ON (B)(6) 2022 A PATIENT UNDERWENT A SPINAL PROCEDURE. DURING THE SURGERY DURING TIGHTENING THE DEVICE TIP FRACTURED OFF IN THE RIGHT L4 SCREW AND COULD NOT BE RETRIEVED FROM THE SCREW. THE DEVICE TIP WAS SEALED THE ENGAGED SCREW BY THE ROD AND LOCK SCREW AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WERE NO ADVERSE EFFECT TO THE PATIENT AS A CONSEQUENCE OF THE DEVICE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14577723 ↗
• MalfunctionMay 31, 2022Fracture; Fracture

  ON (B)(6) 2022 DURING A SPINAL PROCEDURE THE TIP OF THE FINAL LOCK SCREW DRIVER WAS SHEARED OFF AND LEFT IN-SITU COLD-WELDED INTO THE LOCK SCREW.

  Patient problems: Foreign Body In Patient

  MAUDE report 14549938 ↗