NA 03.617.963Recalls & reported problems
Synthes GmbH · AIMING DEVICE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034717296), received between Jan 16, 2017 and Oct 10, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2019Break; Break
UPDATED EVENT DESCRIPTION: IT WAS DETERMINED DURING RECONCILIATION OF LOGISTICS OF RETURNED DEVICES, THE AIMING DEVICE WAS RETURNED BEING LISTED AS BROKEN. THERE WAS NO KNOWN PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9177064 ↗MalfunctionJan 16, 2017Break; Break
THE SERVICE AND REPAIR (S&R) DEPARTMENT REPORTED THAT A SYNTHES EVALUATION EQUIPMENT FAILED INSPECTION. THE AIMING DEVICE LOCKING RAIL IS BROKEN. THE ISSUE WAS IDENTIFIED DURING THE SERVICE & REPAIR ACTIVITIES OF THE EVALUATION SET.
Patient problems: No Patient Involvement
MAUDE report 6253824 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page