33 PASS LP (REF B33126012)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03613720205760), received between Mar 3, 2022 and Jan 23, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2023Break; Break

  INFORMATION RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. PRE-OP DIAGNOSIS WAS MENTIONED AS INITIALLY OPERATED DUE TO A T11 FRACTURE OF THE ROD. MEDICAL HISTORY OF PATIENT INCLUDES OSTEOPOROSIS AND ALREADY OPERATED TO THE SPINE, SCOLIOSIS T10-S1 IN (B)(6) 2017. IT WAS REPORTED THAT, AFTER HIS 24 MONTH ¿ FOLLOW UP PLANNED IN THE CLINICAL STUDY, THE SUBJECT HEARS A NOISE "CRACK" IN HIS BACK; THE X-RAYS CONFIRMED A ROD BREAKAGE FOR THE 2 RODS. NO ADDITIONAL INFORMATION SINCE THE SUBJECT WAS LEFT OF THE CLINICAL STUDY; REMOVAL AND REPLACEMENT OF THE RODS WAS PERFORMED ON (B)(6) 2020. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16221962 ↗
• InjuryJan 23, 2023Break; Break

  INFORMATION RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. PRE-OP DIAGNOSIS WAS MENTIONED AS INITIALLY OPERATED DUE TO A T11 FRACTURE OF THE ROD. MEDICAL HISTORY OF PATIENT INCLUDES OSTEOPOROSIS AND ALREADY OPERATED TO THE SPINE, SCOLIOSIS T10-S1 IN (B)(6) 2017. IT WAS REPORTED THAT, AFTER HIS 24 MONTH ¿ FOLLOW UP PLANNED IN THE CLINICAL STUDY, THE SUBJECT HEARS A NOISE "CRACK" IN HIS BACK; THE X-RAYS CONFIRMED A ROD BREAKAGE FOR THE 2 RODS. NO ADDITIONAL INFORMATION SINCE THE SUBJECT WAS LEFT OF THE CLINICAL STUDY; REMOVAL AND REPLACEMENT OF THE RODS WAS PERFORMED ON (B)(6) 2020. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16221951 ↗
• InjuryJun 23, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR REVISION WITH UNID RODS. IT WAS REPORTED THAT THE REMOVING OF PASS PL WAS NOT EASY WITH THE DISMANTLING SET AND SURGEON LEFT 2-4 SCREWS IN PATIENT BECAUSE OF THE NOT EASY REMOVAL. THE DRIVER WENT LOOSE IN THE TOP SCREW WHEN TRYING TO REMOVE SCREWS. THERE WAS A DELAY IN OVERALL PROCEDURE TIME. THE UNID ROD WAS BROKEN AND REVISION SURGERY WAS PERFORMED FROM TH12 TO S2 AS A RESULT OF THIS EVENT. THE PATIENT HAD INITIAL SURGERY IN FRANCE AND NO FURTHER INFORMATION AVAILABLE REGARDING THE BROKEN ROD. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14789814 ↗
• MalfunctionMar 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM POST MARKET CLINICAL STUDY AND HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS NEUROLOGICAL SPINE DEFORMITY AND MEDICAL HISTORY INCLUDES HIGH BLOOD PRESSURE, SMOKER, POSTERIOR ARTHRODESIS L1S1 WITH OSTEOTOMY. IT WAS REPORTED THAT, THERE WAS A DEVICE PROBLEM - DROP OF INSTRUMENTATION. IT WAS UNKNOWN, IF THERE ANY ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT.  THERE WAS NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13891498 ↗
• MalfunctionMar 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM POST MARKET CLINICAL STUDY AND HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS NEUROLOGICAL SPINE DEFORMITY AND MEDICAL HISTORY INCLUDES HIGH BLOOD PRESSURE, SMOKER, POSTERIOR ARTHRODESIS L1S1 WITH OSTEOTOMY. IT WAS REPORTED THAT, THERE WAS A DEVICE PROBLEM - DROP OF INSTRUMENTATION. IT WAS UNKNOWN, IF THERE ANY ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT.  THERE WAS NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13891277 ↗
• InjuryMar 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION RECEIVED FROM POST MARKET CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS DEGENERATIVE KYPHOSCOLIOSIS AND MEDICAL HISTORY INCLUDES TWO HERNIATED DISCS. IT WAS REPORTED THAT, DISASSEMBLY OF THE MATERIAL ON (B)(6) 2017 AND 7 DAYS AFTER BLEEDING OCCURRED FROM SCAR DUE TO INFECTION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 AND THE ROD WAS CHANGED. IT WAS UNKNOWN, IF ANY ADDITIONAL TREATMENT WAS PERFORMED FOR INFECTION. THE REPORTED ROD WAS DISCARDED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 13658222 ↗
• InjuryMar 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION RECEIVED FROM (B)(6) STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS DEGENERATIVE KYPHOSCOLIOSIS AND MEDICAL HISTORY INCLUDES TWO HERNIATED DISCS. IT WAS REPORTED THAT, DISASSEMBLY OF THE MATERIAL ON (B)(6) 2017 AND 7 DAYS AFTER BLEEDING OCCURRED FROM SCAR DUE TO INFECTION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 AND THE ROD WAS CHANGED. IT WAS UNKNOWN, IF ANY ADDITIONAL TREATMENT WAS PERFORMED FOR INFECTION. THE REPORTED ROD WAS DISCARDED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 13658158 ↗