ANATOMIC PEEK PTC Cervical Fusion System 5030764Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CAGE 5030764 ANATOMIC PTC 16X14X7MM · Class 2 · Implant
Data updated Oct 18, 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 00643169357518), received between Mar 19, 2025 and Mar 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- Mechanical Problem1
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.
MalfunctionMar 19, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A PTC CAGE HAVING C5-7 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) THERAPY FOR TRAUMA WHICH LED TO A CERVICAL FRACTURE. IT WAS REPORTED THAT A PIECE OF THE THREADS FROM THE CAGE HAD COME LOOSE AND DR WAS ABLE TO PULL THE THREAD OUT. THE CAGE WAS STRIPPED. THERE WAS NO REVISION SURGERY PLANNED/ OCCURRED AS A RESULT OF THE EVENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21642893 ↗
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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