Calix Spinal Implant System X034-0241PC-STRRecalls & reported problems
Xtant Medical Holdings, Inc. · 26mm L x 10mm W x 8mm H; Calix-PLIF, PC · 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 M697X0340241PCSTR1), received between Nov 6, 2020 and Nov 6, 2020 — 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.
Most reported problems
Device problems
- Migration1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 6, 2020Migration; Migration
THE COMPANY RECEIVED NOTIFICATION OF 9/24/2020 FROM A SURGICAL FACILITY, THAT REPORTED DURING A PATIENT'S ROUTINE EIGHT-MONTH FOLLOW-UP AN IMPLANT LOCKING CAP WAS IDENTIFIED AS HAVING MIGRATED SINCE THE ORIGINAL PROCEDURE. THE ORIGINAL L5-S1 DECOMPRESSION AND FUSION WITH PEDICLE SCREWS AND INTERBODY SPACER WAS PERFORMED ON (B)(6) 2020 DUE TO PERSONAL INJURY. THERE WERE NO KNOWN PATIENT COMPLICATIONS IDENTIFIED DURING THE ORIGINAL PROCEDURE. THE HEALTH STATUS OF THE PATIENT WAS REPORTED AS, "PATIENT'S GENERAL HEALTH IS WELL. HOWEVER, PATIENT IS EXPERIENCING GREAT PAIN WHEN STANDING, SITTING, AND WALKING." THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS SUBMISSION: 3005031160-2020-00023 AND 3005031160-2020-00026.
Patient problems: Implant Pain
MAUDE report 10802951 ↗
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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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