APEX Spine System 5500-325DRecalls & reported problems
Spinecraft, LLC · APEX Ti Straight Rod Dia.5.50, 325mm, Deformity · 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 00193082004063), received between Oct 19, 2020 and Oct 19, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture1
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.
MalfunctionOct 19, 2020Fracture; Fracture
THE PATIENT FIRST UNDERWENT A SURGERY WHERE A CONSTRUCT WAS PLACED IN SPINE LEVELS L2-S2. ABOUT 2.5 MONTHS POST-OPERATIVELY, THE PATIENT SUFFERED A FRACTURE AT L2 VERTEBRAL BODY (REASON FOR FRACTURE IS UNKNOWN) AND A REVISION SURGERY WAS PERFORMED TO EXTEND THE CONSTRUCT UP TO T10 SPINE LEVEL. DURING A ROUTINE PATIENT FOLLOW-UP APPROXIMATELY 3.5 MONTHS AFTER THIS REVISION-EXTENSION, X-RAY IMAGES REVEALED THAT THE TWO TI 5.5MM DIAMETER DEFORMITY RODS ORIGINALLY IMPLANTED HAD FRACTURED AT THE JUNCTION WHERE THE TANDEM ROD CONNECTORS WERE PLACED TO EXTEND THE CONSTRUCT TO T10. THE PATIENT WAS REVISED AROUND 2 WEEKS AFTER THIS INCIDENT TO REPLACE THE FRACTURED RODS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10698291 ↗
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- 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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