ReLine 10000606Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887517497352), received between Jun 4, 2020 and Feb 17, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Fracture

  IT WAS REPORTED THAT SOME SET SCREWS POPPED OFF AND NOW HAVE TO DO A REVISION. THEY WANT TO ENSURE THAT THE TORQUE LIMITER ON OUR FINAL TIGHTENER IS PROPERLY CALIBRATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369500 ↗
• MalfunctionJan 6, 2026Fracture

  IT WAS REPORTED THAT DURING A REVISION SURGERY FOR A FRACTURED SCREW, THE T-HANDLE WAS TORQUING OUT WAY TOO FAST. THE SET SCREWS WERE STILL LOOSE AFTER ATTEMPTING TO FINAL TIGHTEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973999 ↗
• MalfunctionAug 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT A NUVASIVE TORQUE WRENCH FRACTURED DURING SURGERY RESULTING IN EXTENDED SURGERY TIME AND TISSUE TRAUMA. THIS EVENT OCCURRED IN GERMANY.

  Patient problems: Insufficient Information; Rupture

  MAUDE report 22883646 ↗
• MalfunctionDec 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2021 WHILE THE PATIENT WAS UNDER ANESTHESIA IT WAS DISCOVERED THAT A TORQUE HANDLE WAS LEAKING LIQUID AND THE DEVICE WAS RE-STERILIZED DURING THE CASE, BUT STILL CONTINUED TO LEAK. THE OPERATION COULD NOT BE PERFORMED AS IT WAS UNKNOWN IF THE WHOLE KIT WAS CONTAMINATED. THE CAUSE OF THE LIQUID IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12977137 ↗
• MalfunctionJun 4, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON AN UNKNOWN DATE. AS PER REPORTER, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019 DUE TO LOOSEN LOCK SCREWS. NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10117390 ↗