OPAL 08.803.107Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034754376), received between Oct 24, 2023 and Oct 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A PLIF (L5/S1) WAS PERFORMED. THE SURGEON ATTEMPTED TO REMOVE THE CAGE INSERTED INTO THE RIGHT SIDE BECAUSE IT HAD BEEN INSERTED TOO FAR ANTERIOR. THE CAGE WAS DAMAGED DURING REMOVAL BECAUSE THERE WAS NO DEDICATED DEVICE TO REMOVE IT, THE SURGEON HAD DIFFICULTY REMOVING THE CAGE. ONLY 2 CAGES OF THE SAME SIZE HAD BEEN PREPARED, THE CAGE WITH THE SAME SIZE WAS UNABLE TO BE INSERTED AFTER THE CAGE IN QUESTION WAS DAMAGED. SUBSEQUENTLY, THE SURGEON INSERTED A CAGE SIZED LARGER (9 MM HEIGHT), AND IT WAS SUCCESSFULLY INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN OPAL SPACER 10MM X 28MM 7MM HEIGHT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995992 ↗
• MalfunctionOct 24, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A PLIF (L5/S1) WAS PERFORMED. THE SURGEON ATTEMPTED TO REMOVE THE CAGE INSERTED INTO THE RIGHT SIDE BECAUSE IT HAD BEEN INSERTED TOO FAR ANTERIOR. THE CAGE WAS DAMAGED DURING REMOVAL BECAUSE THERE WAS NO DEDICATED DEVICE TO REMOVE IT, THE SURGEON HAD DIFFICULTY REMOVING THE CAGE. ONLY 2 CAGES OF THE SAME SIZE HAD BEEN PREPARED, THE CAGE WITH THE SAME SIZE WAS UNABLE TO BE INSERTED AFTER THE CAGE IN QUESTION WAS DAMAGED. SUBSEQUENTLY, THE SURGEON INSERTED A CAGE SIZED LARGER (9 MM HEIGHT), AND IT WAS SUCCESSFULLY INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN OPAL SPACER 10MM X 28MM 7MM HEIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995989 ↗