EXPEDIUM 179772040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034270135), received between Feb 4, 2019 and Jan 8, 2024 — classified as 3 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. 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.

• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: NEUROCOMPRESSION COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM PRE-BENT SPINAL ROD 5.5 X 40MM THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 18463755 ↗
• InjuryFeb 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: I HAVE HAD THESE PICTURES AND THE ATTACHED FILE WITH EXPEDIUM PRODUCTS FROM A DOCTOR IN (B)(6). WE HAVE DECIDED TO CALL THE PATIENT (B)(6). IT IS A MALE AND HE IS BORN IN (B)(6). HE WAS OPERATED ON (B)(6) 2018 AND HAD EXPEDIUM IMPLANTED. THERE WERE NO COMPLICATIONS AT AND AFTER SURGERY. 5 DAYS AFTER SURGERY HE SUDDENLY HAD A MASSIVE PAIN AND AN MRI IS DONE AND THESE PICTURES APPEAR. NOW THE DOCTORS WILL LIKE TO KNOW WHAT CAUSES THE MASSIVE BLACKNESS IN THE PICTURES AS IT SEEM MORE THAN NORMAL ARTEFACT. THEIR QUESTION IS IF IT CAN BE SOME KIND OF GALVANIC CURRENCY? OR IF WE HAVE ANOTHER EXPLANATION? I HAVE POINTED OUT THAT ALL THE IMPLANTS ARE TITANIUM (ALSO THE BARS) AS THEY ARE WHAT THEY THINK CAUSES THE PROBLEM, BUT TO MY KNOWLEDGE THIS CANNOT BE SO AS EVERYTHING IS TITANIUM. I AM SENDING THIS TO YOU AS YOU MIGHT HAVE AN IDEA OF WHO TO ASK. OF COURSE THE DOCTORS WILL LIKE TO KNOW WHAT IS GOING ON. THE IMPLANTS ARE STILL IN THE PATIENT SO WE ONLY HAVE THE SHEET WITH THE PRODUCT CODES AND LOT NUMBERS.

  Patient problems: Pain

  MAUDE report 8302453 ↗
• InjuryFeb 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: I HAVE HAD THESE PICTURES AND THE ATTACHED FILE WITH EXPEDIUM PRODUCTS FROM A DOCTOR IN (B)(6). WE HAVE DECIDED TO CALL THE PATIENT (B)(6). IT IS A MALE AND HE IS BORN IN (B)(6). HE WAS OPERATED ON (B)(6) 2018 AND HAD EXPEDIUM IMPLANTED. THERE WERE NO COMPLICATIONS AT AND AFTER SURGERY. 5 DAYS AFTER SURGERY HE SUDDENLY HAD A MASSIVE PAIN AND AN MRI IS DONE AND THESE PICTURES APPEAR. NOW THE DOCTORS WILL LIKE TO KNOW WHAT CAUSES THE MASSIVE BLACKNESS IN THE PICTURES AS IT SEEM MORE THAN NORMAL ARTEFACT. THEIR QUESTION IS IF IT CAN BE SOME KIND OF GALVANIC CURRENCY? OR IF WE HAVE ANOTHER EXPLANATION? I HAVE POINTED OUT THAT ALL THE IMPLANTS ARE TITANIUM (ALSO THE BARS) AS THEY ARE WHAT THEY THINK CAUSES THE PROBLEM, BUT TO MY KNOWLEDGE THIS CANNOT BE SO AS EVERYTHING IS TITANIUM. I AM SENDING THIS TO YOU AS YOU MIGHT HAVE AN IDEA OF WHO TO ASK. OF COURSE THE DOCTORS WILL LIKE TO KNOW WHAT IS GOING ON. THE IMPLANTS ARE STILL IN THE PATIENT SO WE ONLY HAVE THE SHEET WITH THE PRODUCT CODES AND LOT NUMBERS.

  Patient problems: Pain

  MAUDE report 8302157 ↗