ReLine 10055440Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517534699), received between Feb 8, 2022 and May 23, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• MalfunctionMay 23, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A POSTERIOR FIXATION PROCEDURE, THE SURGEON ATTEMPTED TO UNLOCK AND REMOVE THE CROSS-CONNECTOR FROM THE FIXATION RODS; HOWEVER, THE LOCKING CAMS ON BOTH SIDES OF THE CROSS-CONNECTOR COULD NOT BE UNLOCKED. THEREFORE, THE SURGEON HAD TO REMOVE THE RODS AND REPLACE WITH NEW RODS AND A NEW CROSS-CONNECTOR. IT WAS ADDITIONALLY REPORTED THAT THE SURGEON ENCOUNTERED PROBLEMS WITH TIGHTENING THE CROSS-CONNECTOR'S CENTER SCREW WITH A TORQUE HANDLE. THERE WAS NO FURTHER PROCEDURE IMPACT REPORTED AND NO ADVERSE PATIENT IMPACT WAS REPORTED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989410 ↗
• MalfunctionMar 29, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE X-CONNECTOR WAS PLACED ON THE RODS AND AN ATTEMPT WAS MADE TO DISENGAGE IT, BUT IT COULD NOT BE REMOVED FROM THE ROD. THE X-CONNECTOR WAS REMOVED FROM THE SURGICAL FIELD ALONG WITH THE RODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637497 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON A UNKNOWN DATE A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM T10-L5. POST OP THE PATIENT DEVELOPED PROXIMAL JUNCTIONAL KYPHOSIS (PJK) AND ON (B)(6) 2020 IT WAS REPORTED THE PATIENT UNDERWENT A REVISION TO ADDRESS THE PJK BY EXTENDING THE CONSTRUCT FROM T10 TO T5. IT WAS REPORTED THE PATIENT WAS NOT EXPERIENCING ANY ADVERSE SYMPTOMS OTHER THAN THE PJK INDUCED PARALYSIS AND THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Paralysis

  MAUDE report 13483320 ↗