ReLine 16027545Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887517556998), received between Sep 1, 2021 and Sep 3, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Migration” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  (B)(6) 2024: PROCEDURE WHERE TH12, L2, L5, S1 WERE FIXATED BY PPS. (B)(6) 2024: PEDICLE SCREWS WERE FOUND TO HAVE BACKED OUT AT L5 AND S1 ON BOTH SIDES. (B)(6) 2024: REVISION SURGERY. PEDICLE SCREWS AT L5 WERE REPLACED WITH 8.5X45MM, S1 WITH 8.5X45 AND S2 WITH 8.5X70, FIXATED WITH 6.0TI RODS. (3 OF 4) S1 LEFT.

  Patient problems: Arthritis; Tissue Breakdown

  MAUDE report 20131717 ↗
• MalfunctionSep 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  (B)(6) 2024: PROCEDURE WHERE TH12, L2, L5, S1 WERE FIXATED BY PPS. (B)(6) 2024: PEDICLE SCREWS WERE FOUND TO HAVE BACKED OUT AT L5 AND S1 ON BOTH SIDES. (B)(6) 2024: REVISION SURGERY. PEDICLE SCREWS AT L5 WERE REPLACED WITH 8.5X45MM, S1 WITH 8.5X45 AND S2 WITH 8.5X70, FIXATED WITH 6.0TI RODS. (4 OF 4) S1 RT.

  Patient problems: Arthritis; Tissue Breakdown

  MAUDE report 20131715 ↗
• MalfunctionSep 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  (B)(6) 2024: PROCEDURE WHERE TH12, L2, L5, S1 WERE FIXATED BY PPS. (B)(6) 2024: PEDICLE SCREWS WERE FOUND TO HAVE BACKED OUT AT L5 AND S1 ON BOTH SIDES. (B)(6) 2024: REVISION SURGERY. PEDICLE SCREWS AT L5 WERE REPLACED WITH 8.5X45MM, S1 WITH 8.5X45 AND S2 WITH 8.5X70, FIXATED WITH 6.0TI RODS. (2 OF 4) L5 LEFT.

  Patient problems: Arthritis; Tissue Breakdown

  MAUDE report 20131556 ↗
• MalfunctionSep 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  (B)(6) 2024: PROCEDURE WHERE TH12, L2, L5, S1 WERE FIXATED BY PPS. (B)(6) 2024: PEDICLE SCREWS WERE FOUND TO HAVE BACKED OUT AT L5 AND S1 ON BOTH SIDES. (B)(6) 2024: REVISION SURGERY. PEDICLE SCREWS AT L5 WERE REPLACED WITH 8.5X45MM, S1 WITH 8.5X45 AND S2 WITH 8.5X70, RE-FIXATED WITH 6.0TI RODS.

  Patient problems: Arthritis; Tissue Breakdown

  MAUDE report 20131237 ↗
• MalfunctionJan 10, 2022Fracture; Fracture

  ACCORDING TO A CLINICAL STUDY, ON (B)(6) 2021 AN ANTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED AT L4/S1. ON AN UNKNOWN DATE POSTOPERATIVE RADIOGRAPHS REVEALED A RETAINED SCREW EXTENSION TAB AT LEFT S1. ON (B)(6) 2021 THE SCREW EXTENSION TAB WAS REPORTEDLY REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13214071 ↗
• 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. 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 12411328 ↗
• 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 12411299 ↗