PASS LP B02316545ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03613720185383), received between Aug 8, 2023 and Jan 16, 2024 — classified as 3 injuries.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 12, 2023Open, Classified

   There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

   Z-2458-2023 · Root cause: Under Investigation by firm · FDA record ↗

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.

• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER, CLINICAL STUDY VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCT. IT WAS REPORTED THAT, PATIENT HAD ADJACENT LEVEL STENOSIS AT L3-L4 REGION. AS A RESULT, SUBJECT WAS HOSPITALIZED AND CONCOMITANT MEDICATION - CORTICOSTEROIDS WERE ADMINISTERED. THE ADVERSE EVENT WAS TREATED BY PERFORMING ADDITIONAL DECOMPRESSION AND OSTEOSYNTHESIS AT L3-L4. THERE WAS NO ALLEGATION/MALFUNCTION ASSOCIATED WITH REPORTED PASS DEGEN SCREWS. THE LEVELS IMPLANTED WERE L4-L5. INVESTIGATOR ASSESSMENT STATES, THE AE WAS CAUSALLY RELATED TO STUDY PROCEDURE AND NOT RELATED TO STUDY DEVICE AND UNKNOWN TO INSTRUMENTS. SPONSOR ASSESSMENT STATES, THE AE WAS NOT RELATED TO STUDY PROCEDURE AND INSTRUMENTS. POSSIBLY RELATED TO STUDY DEVICE. START DATE OF THE HOSPITALIZATION: (B)(6) 2023 END DATE OF THE HOSPITALIZATION: 07/DEC/2023 DATE OF ADDITIONAL SURGERY IN THE SPINE: (B)(6) 2023 PROXIMAL INSTRUMENTED VERTEBRA: L3 DISTAL INSTRUMENTED VERTEBRA: L5 DATE AE FIRST DETERMINED TO BE AN SAE: (B)(6) 2023.

  Patient problems: Stenosis

  MAUDE report 18515841 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCT. IT WAS REPORTED THAT, PATIENT EXIT THE STUDY DUE TO SPONDYLODISCITIS. PATIENT DEVELOPED SECONDARY INFECTION LINKED TO THE MATERIAL WITH CUTANEOUS START WITH SPONDYLODISCITIS. PATIENT WAS HOSPITALIZED FROM 12/JUL/2020 TO 12/AUG/2020 AND TREATED WITH ANTIBIOTICS. ARTHRODESIS WAS PERFORMED ON 30/JUL/2020. SITE (INVESTIGATOR) ASSESSMENT STATES, ADVERSE EVENT WAS NOT RELATED EITHER TO THE PROCEDURE AND TO THE DEVICE. SPONSOR ASSESSMENT STATES, CAUSAL RELATED TO THE DEVICE BUT, NOT RELATED TO THE PROCEDURE. AE TERM UPDATED: SPONDYLODISCITIS. AE START DATE: 01/JUL/2020 WERE ANY DIAGNOSTIC TESTS PERFORMED: YES. PATIENT RECOVERED ON 09/SEP/2021 NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18245518 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. POST SURGERY, WITH WASHING AND DRAINAGE WAS PERFORMED. BLOOD TEST (CRP = 195). CLINICALLY SIGNIFICANT; YES. DIAGNOSTIC TEST DATE: (B)(6)2018. OTHER (BACTERIOLOGICAL EXAM). DIAGNOSTIC TEST RESULT; STAPHYLOCOCCUS AUREUS. CLINICALLY SIGNIFICANT: YES. DIAGNOSTIC TEST DATE. (B)(6) 2018.

  Patient problems: Fever; Inflammation; Sepsis

  MAUDE report 17478185 ↗