ATLANTIS® Anterior Cervical Plate System 876-614Recalls & reported problems
Medtronic Sofamor Danek, Inc. · BONE SCREW 876-614 VA SELF DRL 4.0X14MM · Class 2 · Implant
All models of ATLANTIS Anterior Cervical Plate System (46)
Data updated Oct 18, 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 00721902175572), received between Oct 24, 2017 and Oct 24, 2017 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Neck Pain1
- Neuropathy1
- Numbness1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PROCEDURE USED: EXTRA PHARYNGEAL ANTEROLATERAL LEVELS IMPLANTED: C5-6, C6-7 IT WAS REPORTED THAT ON (B)(6) 2013, PATIENT WAS DIAGNOSED WITH HIGH-GRADE STENOSIS AT C4-5 AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (C4-5) AND ALLOGRAFT, PLATE FIXATION, AND REMOVAL OF OLD PLATE (C5-7). PATIENT TOLERATED THE PROCEDURE WELL WITH NO COMPLICATIONS. APPROXIMATELY 54 MONTHS POSTOPERATIVELY, THE PATIENT COMPLAINED OF NECK PAIN AND STIFFNESS, DECREASED RANGE OF MOTION, AND OCCASIONAL RADIATION INTO SHOULDERS. TREATMENT INCLUDED A CERVICAL MRI ON (B)(6) 2011 THAT SHOWED C4-C5 DEGENERATIVE DISC DISEASE AND DISC PROTRUSION. THE PATIENT CONSIDERED THE NECK PAIN TOLERABLE AT THIS POINT, SO THE SITE REPORTED THEY WOULD CONTINUE TO OBSERVE. APPROXIMATELY 86 MONTHS POSTOPERATIVELY, THE PATIENT COMPLAINED OF PAIN IN HIS NECK WITH RADIATION TO SHOULDERS AND ARMS, LEFT GREATER THAN RIGHT WITH NUMBNESS IN THE LEFT UPPER EXTREMITY. NO TREATMENT WAS PROVIDED. APPROXIMATELY 88 MONTHS POSTOPERATIVELY, THE PATIENT HAD PROGRESSION OF NECK PAIN AND UPPER EXTREMITY PAIN THAT RESULTED IN SURGERY. AT THE 120-MONTHS POSTOPERATIVE EVALUATION, THE PATIENT HAD RESIDUAL NECK PAIN THAT IS A PERMANENT CONDITION.
Patient problems: Neck Pain; Neuropathy; Numbness
MAUDE report 6970943 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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