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OPAL 08.803.131Recalls & reported problems

Synthes GmbH · OPAL SPACER 10MM X 28MM 11MM HEIGHT-REVOLVE · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034754499), received between Jan 10, 2018 and Jan 10, 2018 — classified as 1 malfunction.

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

Device problems

  • Break1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJan 10, 2018Break; Break

    IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) OPERATION ON (B)(6) 2017, A OPAL SPACER 10MM X 28MM 11MM HEIGHT-REVOLVE BROKE WHEN THE SURGEON WAS TRYING TO IMPLANT IT IN THE DISC SPACE. THE FRAGMENTS GENERATED DUE TO BROKEN DEVICE WERE EASILY REMOVED WITHOUT ANY ADDITIONAL INTERVENTION. THERE WAS 10-15 MINUTES OF SURGICAL DELAY. THE SURGERY WAS COMPLETED WITH ANOTHER AVAILABLE DEVICE. THE PATIENT WAS STABLE AFTER THE SURGERY. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) OPAL SPACER 10MM X 28MM 11MM HEIGHT-REVOLVE. (B)(4).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7179068 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.