CATAMARAN™ SIJ Fusion System 40295-04Recalls & reported problems
Tenon Medical, Inc. · Implant, CAT-04, 10mm x 40mm · 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 00850033676013), received between Jul 13, 2022 and Jul 13, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Adverse Event Without Identified Device or Use Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2022Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem
ON JUNE 1, 2022, QUALITY WAS NOTIFIED OF AN EVENT THAT OCCURRED ON (B)(6) 2022. FOLLOWING IMPLANTATION OF THE DEVICE, IMAGING REVEALED THAT THE SACRUM HAD A SACRAL INSUFFICIENCY FRACTURE ON ITS ANTERIOR CORTEX.
Patient problems: Bone Fracture(s)
MAUDE report 15007395 ↗
Other Sacroiliac Joint Fixation devices
- Firebird SI Fusion 18-1035SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall1 report
- iFuse TORQ Implant System 10065TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall1 report
- iFuse TORQ Implant System 10060TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall1 report
- Firebird SI Fusion 18-2050SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-1065SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2065SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2045SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- iFuse TORQ Implant System 10055TSi-Bone Inc. · Sacroiliac Joint Fixation1 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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