EXPEDIUM 179712750SRecalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 x 7 x 50mm · Class 2 · Implant
All models of EXPEDIUM (291)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034267128), received between Feb 4, 2019 and Feb 4, 2019 — classified as 4 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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Pain4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 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 THE (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 8302649 ↗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 8302590 ↗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 8302523 ↗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 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 THE (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 8302097 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
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- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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