ReLine 16019580Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517554734), received between Jun 3, 2021 and Nov 1, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL POSTERIOR FIXATION PROCEDURE. SUBSEQUENTLY, THE PATIENT REPORTED SYMPTOMS OF PAIN APPROXIMATELY FIVE (5) MONTHS LATER AND EXAMINATION IDENTIFIED THAT BOTH PEDICLE SCREWS AT S2 HAD FRACTURED. A REVISION PROCEDURE WAS PERFORMED APPROXIMATELY SIX (6) MONTHS AFTER THE INITIAL PROCEDURE TO REMOVE AND REPLACE THE FRACTURED SCREWS. DURING THE REVISION PROCEDURE, IT WAS IDENTIFIED THAT BOTH SCREWS AT S1 HAD LOOSENED AND FUSION HAD FAILED TO OCCUR AT THE L5/S1 DISC SPACE. THE SCREWS AT S1 WERE REMOVED AND REPLACED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE. REPORT 2 OF 4.

  Patient problems: Pain

  MAUDE report 15712726 ↗
• InjuryNov 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL POSTERIOR FIXATION PROCEDURE. SUBSEQUENTLY, THE PATIENT REPORTED SYMPTOMS OF PAIN APPROXIMATELY FIVE (5) MONTHS LATER AND EXAMINATION IDENTIFIED THAT BOTH PEDICLE SCREWS AT S2 HAD FRACTURED. A REVISION PROCEDURE WAS PERFORMED APPROXIMATELY SIX (6) MONTHS AFTER THE INITIAL PROCEDURE TO REMOVE AND REPLACE THE FRACTURED SCREWS. DURING THE REVISION PROCEDURE, IT WAS IDENTIFIED THAT BOTH SCREWS AT S1 HAD LOOSENED AND FUSION HAD FAILED TO OCCUR AT THE L5/S1 DISC SPACE. THE SCREWS AT S1 WERE REMOVED AND REPLACED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE. REPORT 1 OF 4.

  Patient problems: Pain

  MAUDE report 15712725 ↗
• MalfunctionSep 28, 2021Fracture; Fracture

  ON (B)(6) 2021 A PATIENT'S KYPHOSIS INCREASED AND THEIR CONSTRUCT WAS EXTENDED FROM T10 TO T4 AND A FRACTURED SCREW AT SAI WAS REPLACED. ON (B)(6) 2021 IT WAS REPORTED THAT THE SAI SCREW FRACTURED. NO REVISION SURGERY IS PLANNED AND NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541392 ↗
• MalfunctionJun 3, 2021Fracture; Fracture

  ON (B)(6) 2020 A POSTERIOR LUMBAR INTERBODY FUSION AT T10/S2AI. ON (B)(6) 2021 A REVISION SURGERY OCCURRED DUE TO A ROD FRACTURE AT LEFT L5/S1 AND A SCREW FRACTURE AT RIGHT S2AI. (2031966-2021-00051) ON (B)(6) 2021 DURING A ROUTINE FOLLOW-UP AN X-RAY REVEALED THAT THE RIGHT S2AI SCREW FRACTURED. BONE FUSION WAS REPORTEDLY COMPLETE AND THE PATIENT'S PHYSICAL ACTIVITY LEVEL WAS NORMAL. THE PHYSICIAN STATED THEY WILL CONTINUE TO MONITOR THE PATIENT. NO REVISION SURGERY PLANNED AND NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930036 ↗