ANATOMIC PEEK PTC Cervical Fusion System 5030664Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CAGE 5030664 ANATOMIC PTC 16X14X6MM · Class 2 · Implant
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 00643169357549), received between Jun 30, 2025 and Jun 30, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2025Migration; Migration
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) REVISION SURGERY FOR HERNIA. IT WAS REPORTED THAT THE CAGE WAS BACKED OUT. THERE WERE NO FURTHER COM PLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22359213 ↗
Other Intervertebral fusion device with bone graft, cervical devices
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- EIT CIF cage CUI8070SEIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Cervical1 recall4 reports
- EIT CIF cage CUI8060LEIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Cervical1 recall1 report
- CONSTRUX - MINI Ti 37-7212SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI Ti 37-8015SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI Ti 37-7206SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI Ti 37-8007SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI PTC 37-4211SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 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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