MaxAn® Anterior Cervical 14-521618ERecalls & reported problems
Biomet Spine LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304984899), received between Nov 2, 2023 and Nov 2, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 2, 2023Fracture; Fracture
IT WAS REPORTED THAT TWO MAXAN SCREWS FRACTURED 4 YEARS POST-OP AT LEVEL C6 OF A 2 LEVEL PLATE AT C4-C6. A REVISION SURGERY WAS PERFORMED WITH THE THREADED PART OF BOTH SCREWS BEING RETAINED IN THE PATIENT; THE FULL CONSTRUCT WAS REPLACED TO C6/C7/T1.THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 18061866 ↗InjuryNov 2, 2023Fracture; Fracture
IT WAS REPORTED THAT TWO MAXAN SCREWS FRACTURED 4 YEARS POST-OP AT LEVEL C6 OF A 2 LEVEL PLATE AT C4-C6. A REVISION SURGERY WAS PERFORMED WITH THE THREADED PART OF BOTH SCREWS BEING RETAINED IN THE PATIENT; THE FULL CONSTRUCT WAS REPLACED TO C6/C7/T1. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 18061858 ↗
Other Appliance, fixation, spinal intervertebral body devices
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- 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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