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OPAL 08.803.052Recalls & reported problems

Synthes GmbH · OPAL SPACER 10MM X 24MM 12MM 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 10705034754345), received between Nov 16, 2017 and Nov 16, 2017 — 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.

  • MalfunctionNov 16, 2017Break; Break

    IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2017 AND WHILE THE SURGEON WAS INSERTING THE OPAL CAGE IMPLANT, THE IMPLANT BROKE DURING THE TURNING OF THE INSERTION. PATIENTS OUTCOME IS FINE AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY REPORTED. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITANT DEVICE REPORTED: INSERTION HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) . THIS REPORT S 1 OF 1 FOR (B)(4).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7037659 ↗

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