OPAL 08.803.210Recalls & reported problems
Synthes GmbH · OPAL SPACER 10MM X 32MM 10MM HEIGHT · Class 2 · Implant
All models of OPAL (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10705034754574), received between Apr 20, 2018 and Apr 20, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.
MalfunctionApr 20, 2018Break; Break
IT WAS REPORTED THAT ON (B)(6) 2018, AN OPAL SPACER BROKE INTO MULTIPLE FRAGMENTS DURING AN INITIAL IMPLANTATION. IT IS UNKNOWN AS TO HOW THE OPAL SPACER BROKE. ALL BROKEN PIECES (FRAGMENTS) WERE RETRIEVED BY THE SURGEON SUCCESSFULLY AND SKILLFULLY. THE SURGEON THEN IMPLANTED ANOTHER SPACER (SAME PART) ALONG WITH UNKNOWN QUANTITY OF PEDICLE SCREWS TO CONCLUDE THE SURGERY BY CLOSING THE PATIENT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGERY WAS DELAYED BY ABOUT TWO TO THREE (2-3) MINUTES. MULTIPLE FLUOROSCOPIC IMAGES WERE TAKEN THROUGHOUT THE PROCEDURE. THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY AND WITHOUT ANY ADDITIONAL INTERVENTIONS. THE PATIENT WAS REPORTED TO BE IN A STABLE CONDITION. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7448281 ↗
Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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