OPAL 08.803.108Recalls & reported problems
Synthes GmbH · OPAL SPACER 10MM X 28MM 8MM 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034754383), received between Feb 4, 2019 and Feb 4, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility1
- Use of Device Problem1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 4, 2019Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN L4-5 MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF), THE SURGEON HAD NOTICED AN INCREASED BLEEDING WHILE WORKING IN THE INTERBODY SPACE. THE PEDICLE SCREWS ON THE CONTRALATERAL SIDE HAS BEEN PLACED AND THE SCREW HOLES WERE MADE ON THE IPSILATERAL (SAME) SIDE OF THE TLIF BUT HAD NOT BEEN PUT IN YET. THE SURGEON NOTICED A SIGNIFICANT AMOUNT OF BLEEDING WHILE USING THE MEDTRONIC NAVIGATION PROBE IN THE DISC SPACE. IT WAS CONTROLLED BUT OOZING DURING THE ENTIRE PORTION OF THE CASE. THE PROBE HAS BROKEN THROUGH THE ANTERIOR PORTION OF THE DISC SPACE WHICH COULD HAVE LED TO THE BLEEDING. AN OPAL CAGE WAS PLACED BY THE SURGEON, A ROD THEN PLACED ON THE SAME SIDE, AND THEN THEY SPUN THE O-ARM WHICH IS A 3D IMAGE OF THE SPINE. THE LATERAL IMAGE CONFIRMED THAT THE SURGEON PLACED THE CAGE TOO FAR ANTERIOR IN THE DISC SPACE SO HE ATTEMPTED TO REMOVE THE CAGE POSTERIORLY. AS HE ATTEMPTED THIS, HE NOTICED INCREASED BLOOD LOSS SO HE DECIDED TO CALL A VASCULAR SURGEON TO COME IN TO ASSIST. THE PATIENT WAS CLOSED FROM THE BACK, THEN FLIPPED SUPINE, AND THE VASCULAR SURGEONS ACCESSED THE SPINE ANTERIORLY TO SEE WHAT WAS CAUSING THE BLE
Patient problems: No Code Available
MAUDE report 8302314 ↗
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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