ReLine 16027540Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887517556981), received between Nov 2, 2018 and Nov 13, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionNov 13, 2025Fracture; Fracture

  AFTER PLACEMENT OF 2 CAGES, INSERT REDUCTION SCREW, PLACED ROD AND FINALIZED. AFTER BREAKING THE TABS, CHECKED THE TAB LENGTH AND CLOSED. THE RIGHT LATERAL TAB OF S1 INTERFERED WITH THE PELVIS AND THE THREAD WAS BROKEN OFF, LEAVING A REMNANT INSIDE THE BODY. POSTOPERATIVE X-RAYS CONFIRMED THE REMAINS. THE RIGHT SIDE WAS DEPLOYED AGAIN, AND THE TAB WAS REMOVED USING HOSPITAL¿S MEDICAL PLIERS TO CLOSE THE WOUND. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED. THIS EVENT OCCURRED IN JAPAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547736 ↗
• InjuryJun 20, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL POSTERIOR FIXATION PROCEDURE UTILIZING PERCUTANEOUS PEDICLE SCREWS. DURING THE PROCEDURE, FOLLOWING IMPLANTATION OF THE PEDICLE SCREW, THE LOCKING SCREW WAS UNABLE TO BE DELIVERED INTO THE REDUCTION SCREW TULIP. SEVERAL LOCK SCREWS WERE ATTEMPTED AND NONE WERE ABLE TO FIT. THE PROCEDURE WAS CONVERTED TO AN OPEN APPROACH TO COMPLETE THE FIXATION. NO PATIENT HARM OR FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14743962 ↗
• MalfunctionSep 1, 2021Migration; Migration

  ON (B)(6) 2021 A PATIENT UNDERWENT A CORPECTOMY THE FIRST OF A TWO-PART PROCEDURE AT T12. ON (B)(6) 2021 THE SECOND PART POSTERIOR FIXATION AT T10/L2 WAS COMPLETED WITHOUT ISSUE. ON (B)(6) 2021 THE PATIENT REPORTED PAIN AND RADIOGRAPHS REVEALED SUBSIDENCE AT T12 AND FOUR SCREWS AT L1 AND L2 BACKED OUT. ON (B)(6) 2021 A REVISION SURGERY WAS CONDUCTED WHERE THE FOUR SCREWS AT L1/2 WERE REPLACED AND THE CONSTRUCT WAS EXTENDED TO T10/L4.

  Patient problems: Pain

  MAUDE report 12411317 ↗
• MalfunctionSep 1, 2021Migration; Migration

  ON (B)(6) 2021 A PATIENT UNDERWENT A CORPECTOMY THE FIRST OF A TWO-PART PROCEDURE AT T12. ON (B)(6) 2021 THE SECOND PART POSTERIOR FIXATION AT T10/L2 WAS COMPLETED WITHOUT ISSUE. ON (B)(6) 2021 THE PATIENT REPORTED PAIN AND RADIOGRAPHS REVEALED SUBSIDENCE AT T12 AND FOUR SCREWS AT L1 AND L2 BACKED OUT. ON (B)(6) 2021 A REVISION SURGERY WAS CONDUCTED WHERE THE FOUR SCREWS AT L1/2 WERE REPLACED AND THE CONSTRUCT WAS EXTENDED TO T10/L4.

  Patient problems: Pain

  MAUDE report 12411255 ↗
• MalfunctionNov 2, 2018Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2018, PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH POSTERIOR FIXATION AT L5/S1 LEVELS. POST-OPERATIVE OBSERVATION IDENTIFIED CAGE SUBSIDENCE AND A LOOSE SCREW. ON (B)(6) 2018 A REVISION PROCEDURE TOOK PLACE THAT CONFIRMED THE LOOSE SCREW AT L5 BUT NO SUBSIDENCE. SURGEON DECIDED TO LEAVE IN-SITU AND EXTENDED THE CONSTRUCT TO L4-S2A1. NO PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8034904 ↗