DOLOMITE LDD000006Recalls & reported problems
Astura Medical · ACSS ZERO PLATE, SPIKE · Class 2 · Implant
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 00840085250705), received between Mar 14, 2025 and Mar 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
- Patient Device Interaction Problem1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2025Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth
A FOREIGN PART APPEARED ON THE CT SCAN. A REVISION SURGERY REPORTEDLY FOUND "A WIRE" WHICH WAS PRESUMBALY CAUSED BY SOME SHEERED THREADING FROM THE SCREW. THE ACTUAL IMPLANTS WERE NOT RETURNED.
Patient problems: Implant Pain
MAUDE report 21608455 ↗
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- NA 03.617.904Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical27 reports
- Divergence® Anterior Cervical Fusion System G6626746Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical21 reports
- NA 03.647.972Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical17 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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