LIGAPASS B08110010Recalls & reported problems
Medicrea International · LIGAPASS 2.0 DUAL BAND · Class 2
- 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 03613720271284), received between Jun 18, 2026 and Jun 18, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionJun 18, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING SPINE ARTHR ODESIS. IT WAS REPORTED THAT AT THE TIME OF TIGHTENING THE LIGAPASS DUAL BAND LINKS FAILED AT THE END OF THE TENSIONING. THE PHYSICIAN CHANGED LINKS 3 TIMES TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE BANDS BROKE AT THE END OF POWERING ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25547395 ↗
Other Bone Fixation Cerclage, Sublaminar devices
- TRANSLACE™ Spinal Tethering System 8219500Medtronic Sofamor Danek, Inc. · Bone fixation cerclage, sublaminar11 reports
- VersaTie 86101245Nuvasive, Inc. · Bone fixation cerclage, sublaminar4 reports
- KARMA 75035-175Spinal Elements, Inc. · Bone Fixation Cerclage, Sublaminar3 reports
- VersaTie 8510260Nuvasive, Inc. · Bone fixation cerclage, sublaminar3 reports
- LIGAPASS B08110005Medicrea International · Bone Fixation Cerclage, Sublaminar3 reports
- JAZZ LOCKImplanet · Bone Fixation Cerclage, Sublaminar3 reports
- NILE™ Alternative Fixation System 5416-F04730-SGVB Spine LLC · Bone fixation cerclage, sublaminar2 reports
- VersaTie 8450001Nuvasive, Inc. · Bone fixation cerclage, sublaminar2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.