ReLine 16026550Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517556646), received between Apr 8, 2020 and Sep 20, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2022Sharp Edges; Sharp Edges

  ON (B)(6) 2020 DURING A SPINAL PROCEDURE THE SURGEON MOVED THE REDUCTION TABS MEDIAL LATERAL IN ORDER TO BREAK OFF AN IMPLANTED REDUCTION SCREW. WHEN DOING THIS ONE OF THE DISTAL TIPS OF THE REDUCTION SCREW FRACTURED OFF PIECE AND CUT THE SURGEON¿S SKIN ACROSS THE FINGER ON HIS LEFT HAND. NO SIGNIFICANT HARM OCCURRED. THE SURGEON UNSCRUBBED, CLEAN HIS HAND WITH ANTISEPTIC, COVER THE CUT WITH A STERILE DRESSING & CONTINUE TO OPERATION. THE CUT WAS SMALL BUT BROKE THE SKIN.

  Patient problems: Laceration(s)

  MAUDE report 15458144 ↗
• MalfunctionJul 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL FOUR LEVEL POSTERIOR FIXATION PROCEDURE FROM T11 TO L3. SUBSEQUENTLY, THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE HARDWARE DUE TO COMPLETION OF BONE FUSION APPROXIMATELY 15 MONTHS LATER. DURING THE REMOVAL PROCEDURE, IT WAS IDENTIFIED THAT THE PEDICLE SCREW SHANK AT L3 HAD FRACTURED AND THE DISTAL END WAS UNABLE TO BE REMOVED FROM THE VERTEBRAL BODY. THE FRACTURE SCREW WAS RETAINED BY THE PATIENT. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136537 ↗
• MalfunctionApr 8, 2020Migration; Migration

  ON (B)(6) 2020, PATIENT UNDERWENT A SPINAL PROCEDURE WITH RELINE MAS ON THE T12/S2AI LEVELS. AS PER REPORTER PATIENT EXPERIENCED A FALL CAUSING SCREWS TO LOOSEN AT T12 AND L1 LEVELS. ON (B)(6) 2020 PATIENT UNDERWENT A REVISION PROCEDURE. IT WAS REPORTED THAT THE SCREWS AT T10, T11, T12 AND L1 WERE REPLACED.

  Patient problems: Fall

  MAUDE report 9936650 ↗