OPAL 08.803.053Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034754352), received between Aug 7, 2017 and Feb 1, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, AN OPAL SPACER APPEARED TO BREAK DURING INSERTION. THIS OCCURRED AT LEVELS L5-S1 WITH THE USE OF AN PISTOL GRIP INSERTER DURING ROTATION INTO IT'S FINAL POSITION USING THE RECOMMENDED TECHNIQUE. SURGICAL PROCEDURE WAS A L3-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). ALL FRAGMENTS GENERATED WERE EASILY RETRIEVED WITHOUT THE NEED FOR ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER OPAL SPACER. NO HARM CAME TO THE PATIENT. CONCOMITANT MEDICAL PRODUCTS REPORTED: PISTOL GRIP INSERTER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) OPAL SPACER 10MM X 24MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8297587 ↗
• MalfunctionSep 17, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, A 13MM OPAL REVOLVE SPACER WAS CRACKED WHEN AN INTERBODY SPACER WAS PLACED DURING AN L4 - S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). THE L4-L5 DISC SPACER WAS PREPARED AND SIZED FOR THE INTERBODY SPACER. THE 13MM OPAL REVOLVE WAS INSERTED INTO THE SPACER AND UPON INITIAL ROTATION, IT WAS AUDIBLY CRACKED. THE SURGEON VISUALLY SAW THAT THE IMPLANT HAD BROKEN AND CONFIRMED IT ON THE FLUOROSCOPIC IMAGING. THE BREAKAGE RESULTED IN SEVERAL FRAGMENTS THAT WERE ALL REMOVED AFTER 30 MINUTES. ANOTHER SPACER OF THE SAME SIZE WAS IMPLANTED SUCCESSFULLY. PATIENT STATUS AND SURGICAL OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: OPAL IMPLANT HOLDER, PISTOL GRIP (PART# 03.803.002, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7880369 ↗
• MalfunctionDec 18, 2017Break; Break

  IT WAS REPORTED THAT AN OBLIQUE POSTERIOR ATRAUMATIC LUMBAR (OPAL) SPACER BROKE DURING A POSTERIOR LUMBAR INTERBODY FUSION THAT WAS PERFORMED ON (B)(6) 2017. AS THE SURGEON WAS INSERTING THE SPACER; WHEN HE TRIED TO RE-POSITION IT, THE BACK CORNER OF THE SPACER BROKE OFF. ALL THE FRAGMENTS WERE RETRIEVED. ANOTHER OPAL SPACER WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY WITHOUT ANY DELAY. THE PATIENT OUTCOME WAS AS EXPECTED. THIS REPORT IS FOR ONE (1) OPAL SPACER 10 MM X 24 MM 13 MM HEIGHT-REVOLVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7126657 ↗
• InjuryAug 7, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L2 TO L4. DURING THE PROCEDURE, THE OBLIQUE POSTERIOR ATRAUMATIC LUMBAR (OPAL) SPACER BROKE INTO PIECES. WHILE ATTEMPTING TO REMOVE THE TWO (2) BROKEN PIECES OF THE OPAL SPACER WITH A KERRISON ROUNGER, ADDITIONAL FRAGMENTS WERE GENERATED. ALL FRAGMENTS WERE REMOVED. A NEW SPACER WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS FINE. IT WAS REPORTED THAT ALL FRAGMENTS WERE REMOVED. ON (B)(6) 2017, MANUFACTURER INVESTIGATION NOTED THAT FOUR OF THE FRAGMENTS WERE RETURNED BUT SOME OF THE FRAGMENTS ARE MISSING. THIS REPORT IS FOR ONE (1) OPAL SPACER HEIGHT-REVOLVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6770242 ↗