MOSS 175526000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034033488), received between Jul 31, 2019 and Jul 22, 2021 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT, THE PATIENT WAS SCHEDULED FOR A PLIF REVISION SURGERY (EXTENSION UP TO L3-4 WITH EXPEDIUM SYSTEM) ON (B)(6) 2021. ORIGINALLY, THE PATIENT UNDERWENT FOR PRIMARY PLIF PROCEDURE BETWEEN L4-5 ON (B)(6) 2003. THE MOSS-MIAMI IMPLANTS IN QUESTION NEED TO BE REPLACED WITH EXPEDIUM IMPLANTS IN THE REVISION PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) M-M 5.5 INNER SCREW, TI. THIS REPORT IS 11 OF 14 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12213998 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT, THE PATIENT WAS SCHEDULED FOR A PLIF REVISION SURGERY (EXTENSION UP TO L3-4 WITH EXPEDIUM SYSTEM) ON (B)(6) 2021. ORIGINALLY, THE PATIENT UNDERWENT FOR PRIMARY PLIF PROCEDURE BETWEEN L4-5 ON (B)(6) 2003. THE MOSS-MIAMI IMPLANTS IN QUESTION NEED TO BE REPLACED WITH EXPEDIUM IMPLANTS IN THE REVISION PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES (6) DEVICES. THIS REPORT IS FOR (1) M-M 5.5 INNER SCREW, TI. THIS REPORT IS 8 OF 14 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12213312 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT, THE PATIENT WAS SCHEDULED FOR A PLIF REVISION SURGERY (EXTENSION UP TO L3-4 WITH EXPEDIUM SYSTEM) ON (B)(6) 2021. ORIGINALLY, THE PATIENT UNDERWENT FOR PRIMARY PLIF PROCEDURE BETWEEN L4-5 ON (B)(6) 2003. THE MOSS-MIAMI IMPLANTS IN QUESTION NEED TO BE REPLACED WITH EXPEDIUM IMPLANTS IN THE REVISION PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) M-M 5.5 INNER SCREW, TI. THIS REPORT IS 9 OF 14 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12213311 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT, THE PATIENT WAS SCHEDULED FOR A PLIF REVISION SURGERY (EXTENSION UP TO L3-4 WITH EXPEDIUM SYSTEM) ON (B)(6) 2021. ORIGINALLY, THE PATIENT UNDERWENT FOR PRIMARY PLIF PROCEDURE BETWEEN L4-5 ON (B)(6) 2003. THE MOSS-MIAMI IMPLANTS IN QUESTION NEED TO BE REPLACED WITH EXPEDIUM IMPLANTS IN THE REVISION PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) M-M 5.5 INNER SCREW, TI. THIS REPORT IS 7 OF 14 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12213294 ↗
• InjuryJul 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BREAKAGE POST-OP. IT WAS REPORTED THAT THE PATIENT'S INDICATION IS LUMBAR SPINAL STENOSIS, CAUDA EQUINA SYNDROME. DID THE OPERATION OF L4/S1MM, INTERNAL FIXATION, LAMINECTOMY ON (B)(6) 2005 IN (B)(6) HOSPITAL OF (B)(6) UNIVERSITY. THE PATIENT LEFT FROM HOSPITAL ON (B)(6) 2005. THE PATIENT FELT PAINFUL AND CHECKED IN (B)(6) PEOPLE'S HOSPITAL, NOTED SCREW AND NODE WERE BROKEN. NOW THE PATIENT REJECTS TO DO 2ND SURGERY AND SUED HOSPITAL AND J&J. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: Pain

  MAUDE report 8848057 ↗