OPAL 08.803.051Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034754338), received between May 3, 2018 and May 3, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2018Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TWO LEVEL MINIMALLY INVASIVE TRANSFORMATION LUMBAR INTERBODY FUSION (MIS TLIF) ON (B)(6) 2018 TREATING THE LUMBOSACRAL LEVELS 4/5 (L4/L5) AND 5/1 (L5/L1) WITH AN OPAL SPACER. ONLY THE SPACER AT THE L4/5 LEVEL RETRO PULSED. THE SPACER AT L5/S1 STAYED IN PLACE. AFTER SIX (6) WEEKS OF TAKING A FEW FALLS, THE PATIENT HAD EXPERIENCED BACK PAIN AND SOUGHT OUT MEDICAL ATTENTION. THE SPACERS WERE FIXED WITH A PEDICLE SCREW AND ROD CONSTRUCT AND THOSE WERE NOT AFFECTED BY THE PATIENT FALLS. ADDITIONALLY, IT WAS ALSO REPORTED THAT UPON X-RAY, THE PATIENTS INTER BODY SPACER AT THE L4/L5 HAD RETRO PULSED. IN ORDER TO TREAT THE PATIENT, THE SURGEON INTENDS TO PERFORM A PROCEDURE ANTERIORLY TO REMOVE THE RETRO PULSED SPACER AND RE-INSTRUMENT WITH A LOCKING STAND-ALONE SPACER. AN ANTERIOR PROCEDURE WAS SCHEDULED FOR (B)(6) 2018 TO REMOVE THE SPACER AND RE-INSTRUMENT WITH AN ANTERIOR SPACER. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7483619 ↗