Calix Spinal Implant System C003-0028Recalls & reported problems
Xtant Medical Holdings, Inc. · Specialty Calix-C Rasp without stops - 7 mm · Class 1 · 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 M697C00300281), received between Jan 18, 2019 and Jan 18, 2019 — 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 Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 18, 2019Fracture; Fracture
THE COMPLAINANT REPORTED THAT A RASP BROKE OFF THE HANDLE WHILE THE SURGEON WAS REMOVING THE RASP FROM THE PATIENT. THE SURGEON SUCCESSFULLY REMOVED THE RASP AND THERE WERE NO KNOWN PATIENT COMPLICATIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8262753 ↗
Other RASP devices
- ATTUNE 2545-00-048Depuy (Ireland) · RASP22 reports
- P.F.C. 85-3927Depuy (Ireland) · RASP11 reports
- DePuy Sythes 10-306-000Symmetry Medical Inc. · Rasp11 reports
- EXACT REVERSE FP FULL TOOTH RASP SSI005613Zimmer, Inc. · Rasp3 reports
- EXACT REVERSE FP FULL TOOTH RASP SSI005610Zimmer, Inc. · Rasp3 reports
- EXACT REVERSE FP FULL TOOTH RASP SSI005614Zimmer, Inc. · Rasp3 reports
- ALIF 389.156Synthes GmbH · RASP3 reports
- ALIF 03.808.101Synthes GmbH · RASP2 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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