ReLine 10055445Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887517534705), received between Sep 29, 2017 and Mar 2, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 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.

• MalfunctionMar 2, 2023Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  ON (B)(6) 2022 A PATIENT WAS UNDERWENT A POSTERIOR FIXATION PROCEDURE. DURING THE PROCEDURE WHEN INSTALLING A CROSS CONNECTOR ONE SIDE FASTENED BUT WHEN THE SURGEON TRIED TO DISENGAGE IT THERE WAS NO RESISTANCE TO THE LOCKING CAM. THE SURGEON OPTED TO NOT IMPLANT A CROSS CONNECTOR AS HE WAS CONFIDENT IN THE INSTALLED FIXATION WITHOUT IT. THE SURGERY WAS COMPLETED WITH NO ISSUE OR ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16474296 ↗
• MalfunctionFeb 28, 2023Device Damaged by Another Device; Device Damaged by Another Device

  ON (B)(6) 2023 DURING A SPINAL PROCEDURE THE LATERAL SET SCREW ROTATED BEYOND THE SILVER INDICATOR ARCH DURING FINAL TIGHTENING OVER THE ROD, ULTIMATELY FAILING AND DISCONNECTING FROM THE IMPLANT DURING SURGERY. ALL PIECES WERE RETRIEVED AND THERE WAS NO PATIENT/USER INJURY OR ADVERSE CONSEQUENCE AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455699 ↗
• MalfunctionNov 1, 2022Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  ON (B)(6) 2022 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM L4 TO L5. DURING THE PROCEDURE WHILE ATTEMPTING TO AFFIX A CROSS CONNECTOR THE DEVICE LOCKING CAM APPEARED TO BE DAMAGED. THE SURGEON ATTEMPTED TO REMOVE THE ENGAGED DRIVER BUT IT WAS CAUGHT ON THE DRIVER HEAD AND HAD TO BE FORCIBLY REMOVED BREAKING THE IMPLANT. NO PATIENT INJURY OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712001 ↗
• MalfunctionAug 15, 2022Failure to Disconnect; Failure to Disconnect

  ON (B)(6) 2021 A PATIENT UNDERWENT A SPINAL PROCEDURE. ON (B)(6) 2022 A REVISION WAS COMPLETED FOR REASONS UNKNOWN WHERE THE SURGEON ATTEMPTED TO REMOVE THE X-CONNECTOR, BUT THE SCREW THREAD WAS SMASHED AND COULD NOT BE REMOVED REQUIRING THE RODS TO BE REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229895 ↗
• MalfunctionSep 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2017, A PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE AT L4/5 LEVELS. ON (B)(6) 2017 POST-OPERATIVE RADIOGRAPHS SHOWED SEPARATION OF THE CONNECTOR FROM THE ROD. THE PATIENT IS ASYMPTOMATIC AND NO REVISION SURGERY IS PLANNED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 6904163 ↗