3DP Cervical Interbody System 1Recalls & reported problems
Genesys Orthopedics Systems LLC · 6mm 3DP Stand-Alone Cervical Interbody, Large, Lordotic · 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 M719GAC3D06LL0), received between May 25, 2023 and May 25, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
GENESYS SPINE RECEIVED A COMPLAINT FROM DISTRIBUTOR STRYKER ON MARCH 25, 2023 STATING "WE'VE RECEIVED A COMPLAINT FROM THE FIELD INVOLVING ONE GAC3D-06LL: 6MM 3DP STAND-ALONE CERVICAL LARGE, GAC-LG LORDOTIC AND ONE AIS-LC CERVICAL ANCHOR; LARGE; EVENT DESCRIPTION NOTES "ONE DAY POST OP, THE ANCHOR GOING UP INTO C3 BEGAN TO BACK OUT OF THE BONE AND LOCKING MECHANISM. THE ONE ANCHOR IMMEDIATELY STARTED TO BACK OUT 1 DAY AFTER THE COMPLETION OF THE CASE. WHEN IT WAS NOTICED ON IMAGING THAT THE ONE ANCHOR WAS FREE FLOATING IN THE PATIENT'S NECK, THE DOCTOR'S PARTNER IMMEDIATELY BOOKED THE CASE TO REMOVE THE ANCHOR"." REVISION WAS PERFORMED ON (B)(6) 2023 TO REMOVE THE GENESYS SPINE HARDWARE AND REPLACE WITH ANCHOR-C.
Patient problems: Failure of Implant
MAUDE report 17002716 ↗
Other Intervertebral Fusion Device With Integrated Fixation, Cervical devices
- NA 03.617.902Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical103 reports
- NA 03.617.900Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical77 reports
- Divergence® Anterior Cervical Fusion System G6626525Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical75 reports
- Divergence® Anterior Cervical Fusion System G6626526Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical49 reports
- NA 03.617.905Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical29 reports
- 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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