33 PASS LP (REF B33226012)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03613720205883), received between Dec 25, 2022 and Nov 5, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionNov 5, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR CORRE CTION WITH SCREW AND RODS FOR AN INDICATION OF SCOLIOSE IDIOPATHIQUE - NIVEAUX T2-L1 - TIGES COCR 6 - CYPHOSE T4-T12 30° - POURCENTAGE DE CORRECTION 80%. IT WAS REPORTED THAT ONE CONVEX ROD BROKE DURING CORRECTION FOR MODERATE DEFORMATION. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608213 ↗
• InjuryDec 25, 2022Break; Break

  INFORMATION RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS SCOLIOSIS. MEDICAL HISTORY OF PATIENT INCLUDE SMOKING. IT WAS REPORTED THAT, BREAKAGE OF 2 RODS. THE RODS WERE BROKEN AT LUMBAR SCOLIOSIS LEVEL. AS A RESULT, ADDITIONAL SURGERY WAS PERFORMED. THE PROCEDURE OR TECHNIQUE PERFORMED WAS THORACO LUMBAR ARTHRODESIS AND THE LEVELS IMPLANTED WERE T10-S1. PRODUCT IDENTIFIERS ARE UNKNOWN, BOTH THE BROKEN UNID RODS WERE EXPLANTED DURING REVISION SURGERY AND THEY WERE DISCARDED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16046015 ↗
• InjuryDec 25, 2022Break; Break

  INFORMATION RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS SCOLIOSIS. MEDICAL HISTORY OF PATIENT INCLUDE SMOKING. IT WAS REPORTED THAT, BREAKAGE OF 2 RODS. THE RODS WERE BROKEN AT LUMBAR SCOLIOSIS LEVEL. AS A RESULT, ADDITIONAL SURGERY WAS PERFORMED. THE PROCEDURE OR TECHNIQUE PERFORMED WAS THORACO LUMBAR ARTHRODESIS AND THE LEVELS IMPLANTED WERE T10-S1. PRODUCT IDENTIFIERS ARE UNKNOWN, BOTH THE BROKEN UNID RODS WERE EXPLANTED DURING REVISION SURGERY AND THEY WERE DISCARDED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16046013 ↗