LIGAPASS B08110005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03613720271277), received between Sep 18, 2023 and Dec 7, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCT. MEDICAL HISTORY OF PATIENT INCLUDES BAD BONE QUALITY, HEAVY KYPHOSIS. IT WAS REPORTED THAT, LIGA PASS BANDS WERE BROKEN. FOUR LEVELS WERE IMPLANTED DURING INITIAL SURGERY. PATIENT EXPERIENCED PAIN AS A RESULT AND REVISION SURGERY WAS PERFORMED TO EXPLANT THE BROKEN BAND. THERE WAS NO FRAGMENT OF BROKEN BAND LEFT INSIDE PATIENT BODY. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 18280942 ↗
• InjurySep 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PJK PREVENTION AT TOP OF CONSTRUCT FOR AN INDICATION OF DEFORMITY CORRECTION. IT WAS REPORTED THAT THE PATIENT HAD NEUROLOGICAL SYMPTOMS POST-OP AND NEEDED A DECOMPRESSION. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2023 FOR DECOMPRESSION AND WHILE DOING THE REVISION SURGERY, THE SURGEON DECIDED TO REMOVE THE LIGAPASS DEVICE AS HE FELT THAT THE BAND WAS TOO TIGHT AND THE BAND WENT THROUGH THE 2ND SPINAL PROCESS ABOVE THE UPPER INSTRUMENTED SPINOUS PROCESS WHICH IS TOO HIGH TO BE USEFULL AND HAD SPINOUS PROCESS FRACTURED. THERE WAS NO INDICATION THAT THE PRODUCT HAS FAILED AND THE EVENT COULD BE RESULT OF TECHNIQUE OF INSERTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 17786716 ↗
• InjurySep 18, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PJK PREVENTION AT TOP OF CONSTRUCT FOR AN INDICATION OF DEFORMITY CORRECTION. IT WAS REPORTED THAT THE PATIENT HAD NEUROLOGICAL SYMPTOMS POST-OP AND NEEDED A DECOMPRESSION. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2023 FOR DECOMPRESSION AND WHILE DOING THE REVISION SURGERY, THE SURGEON DECIDED TO REMOVE THE LIGAPASS DEVICE AS HE FELT THAT THE BAND WAS TOO TIGHT AND THE BAND WENT THROUGH THE 2ND SPINAL PROCESS ABOVE THE UPPER INSTRUMENTED SPINOUS PROCESS WHICH IS TOO HIGH TO BE USEFULL AND HAD SPINOUS PROCESS FRACTURED. THERE WAS NO INDICATION THAT THE PRODUCT HAS FAILED AND THE EVENT COULD BE RESULT OF TECHNIQUE OF INSERTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 17763137 ↗