APEX Spine System 6000-300DRecalls & reported problems
Spinecraft, LLC · Titanium Rod 6.0 x 300mm, 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 M8246000300D1), received between Aug 9, 2017 and Aug 9, 2017 — 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
- Discomfort1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2017Fracture; Fracture
APPROXIMATELY 3 MONTHS POST-OP, PATIENT EXPERIENCED A "POP" IN HER BACK AND COMPLAINED OF SOME DISCOMFORT. X-RAYS REVEALS THAT ONE OF THE Ø6.0 MM TITANIUM RODS IN THE LUMBAR REGION IS FRACTURED. HOWEVER, THERE WAS NO LOSS OF ALIGNMENT AND NO SUBSTANTIAL PAIN. AT THIS TIME, THERE IS NO REVISION SURGERY SCHEDULED, AND THE DEVICES REMAIN IMPLANTED. PATIENT WILL CONTINUE TO BE MONITORED BY THE SURGEON. IT IS REPORTED THAT REVISION SURGERY IS TO BE CONSIDERED IF THERE IS A LOSS OF ALIGNMENT DURING SUBSEQUENT FOLLOW UP VISITS.
Patient problems: Discomfort; Pain
MAUDE report 6777248 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
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- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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