ReLine D10000332Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517497383), received between Nov 11, 2022 and Jun 11, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• MalfunctionJun 11, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ON (B)(6) 2024 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM L4-L5. DURING THE PROCEDURE WHEN THE GUIDE ATTACHED TO THE L4 SCREW WAS ATTEMPTING TO BE REMOVED, THE SILVER ROTATING PORTION OF THE DEVICE DETACHED. THE GUIDE WAS REMOVED BY FORCING IT OPEN BY INSERTING AN INSTRUMENT FROM THE FACILITY INTO THE SLOT OF THE GUIDE AND ROTATING IT 90 DEGREES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515618 ↗
• MalfunctionSep 18, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE. DURING THE PROCEDURE, AFTER THE PEDICLE SCREW WAS ATTACHED TO THE RELINE MAS GUIDE, THE GUIDE BECAME STUCK AND WAS UNABLE TO BE DISENGAGED FROM THE SCREW. THE SCREW AND GUIDE WERE REMOVED AND A NEW SCREW AND GUIDE WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769778 ↗
• MalfunctionNov 11, 2022Fracture; Fracture

  ON (B)(6) 2022 DURING A POSTERIOR PROCEDURE, THE GUIDE TIP FRACTURED AND REMAINED ATTACHED TO THE IMPLANTED PEDICLE SCREW TULIP. THE FRACTURED PORTION WAS NOT ABLE TO BE RETRIEVED AND THEREFORE IS BELIEVED TO REMAIN IN THE PATIENT; HOWEVER, POST-OPERATIVE IMAGING COULD NOT DETECT THE FRACTURED PIECE. THERE WERE NO REPORTED TECHNIQUE OR OTHER USE ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FRACTURE. NO ADVERSE PATIENT IMPACT HAS BEEN REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15784300 ↗