ReLine 10000780Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00887517561039), received between Jul 11, 2022 and Jun 16, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Fracture

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF. THE PIECE WAS LEFT IN, BUT IT WAS FINAL TIGHTENED, SO IT IS WELDED TO THE LOCKING CAP. NO ADVERSE EFFECT TO THE PATIENT AND IT WAS NOT A REVISION.

  Patient problems: Foreign Body In Patient

  MAUDE report 25522148 ↗
• MalfunctionJan 10, 2025Fracture; Fracture

  DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE, THE DISTAL TIP OF FINAL DRIVER SHEARED OFF IN AN UNKNOWN LEVEL ON THE LEFT SIDE WHILE ATTEMPTING TO FINAL TIGHTEN. THE FRACTURED PORTION WAS RETAINED IN THE IMPLANT SO THE SURGEON OPTED TO LEAVE THE PORTION IN SITU. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21130122 ↗
• MalfunctionJan 10, 2025Fracture; Fracture

  DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION FROM L3 TO L4, THE DISTAL TIP OF A FINAL DRIVER SHEARED OFF IN AN UNKNOWN LEVEL ON THE RIGHT SIDE WHILE ATTEMPTING TO FINAL TIGHTEN. THE FRACTURED PORTION WAS RETAINED IN THE IMPLANT SO THE SURGEON OPTED TO LEAVE THE PORTION IN SITU. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21130031 ↗
• 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 20055919 ↗
• MalfunctionJan 23, 2024Fracture; Fracture

  NEW OR CORRECTED INFORMATION LISTED ON SECTION H10.

  Patient problems: Foreign Body In Patient

  MAUDE report 18567296 ↗
• MalfunctionOct 16, 2023Fracture; Fracture

  IT WAS REPORTED THE TIP OF THE DRIVER FRACTURED OFF INTO THE SET SCREW AT RIGHT L4 AND COULD NOT BE RETRIEVED; THE FRACTURED TIP REMAINS LODGED IN THE SET SCREW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17940890 ↗
• MalfunctionJun 21, 2023Fracture; Fracture

  IT WAS REPORTED THE TIP OF THE DRIVER FRACTURED OFF WHILE FINAL TIGHTENING THE LOCK SCREW DURING A POSTERIOR PROCEDURE AT L3/5; THE BROKEN PIECE 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 17173325 ↗
• MalfunctionMar 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A SPINAL PROCEDURE THE FINAL LOCK SCREW DRIVER DISTAL TIP BROKE OFF COMPLETELY. THE DISTAL TIP BROKE OFF AND WAS COLD WELDED INTO THE LOCK SCREW AND WAS UNABLE TO BE RETRIEVED. NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16506884 ↗
• MalfunctionOct 14, 2022Fracture; Fracture

  DURING A CASE WHILE UNDERGOING FINAL TIGHTENING OF A PERCUTANEOUS PEDICLE SCREW, THE TIP OF A SCREW DRIVER FRACTURED AND REMAINED IN THE SCREW. THE FRACTURED TIP WAS UNABLE TO BE RETRIEVED. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15609585 ↗
• MalfunctionAug 31, 2022Fracture; Fracture

  ON (B)(6) 2022 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE. DURING FINAL TIGHTENING THE DRIVER TIP FRACTURED OFF IN THE FENESTRATED SCREW AT LEFT L4. IT WAS REPORTED TO BE COLD WELDED INTO THE ENGAGED SCREW AND WAS LEFT IN PATIENT ENCOMPASSED FLUSH IN THE SET SCREW. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329133 ↗
• MalfunctionJul 11, 2022Fracture; Fracture

  ON (B)(6) 2022 DURING A SPINAL PROCEDURE IT WAS REPORTED THAT THE DEVICE WOULD NOT TORQUE CAUSING THE TIP OF THE FINAL LOCK SCREWDRIVER SHAFT TO SNAP OFF DURING FINAL TIGHTENING AT RIGHT L5. THE TIP OF THE DRIVER WAS LEFT COLD WELDED INTO THE SET SCREW AND COULD NOT BE RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14982603 ↗