EXPEDIUM 179988645Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 6.35 x 6 x 45mm · Class 2 · Implant
All models of EXPEDIUM (291)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034093314), received between Oct 7, 2019 and Oct 7, 2019 — classified as 6 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Loose or Intermittent Connection6
Patient problems
- No Code Available6
- No Consequences Or Impact To Patient6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryOct 7, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT WAS RETURNED TO THE OR ONE WEEK POST-OP BECAUSE SURGEON SUSPECTED AN INFECTION (NOT RELATED TO THE HARDWARE). SINCE WE WERE GOING TO HAVE THE INCISION OPENED, THE SURGEON DECIDED TO RETIGHTEN THE SCREWS. ALMOST ALL OF THEM WERE VERY LOOSE. THERE WAS NO PATIENT CONSEQUENCE. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 9163388 ↗InjuryOct 7, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT WAS RETURNED TO THE OR ONE WEEK POST-OP BECAUSE SURGEON SUSPECTED AN INFECTION (NOT RELATED TO THE HARDWARE). SINCE WE WERE GOING TO HAVE THE INCISION OPENED, THE SURGEON DECIDED TO RETIGHTEN THE SCREWS. ALMOST ALL OF THEM WERE VERY LOOSE. THERE WAS NO PATIENT CONSEQUENCE. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 9163105 ↗InjuryOct 7, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT WAS RETURNED TO THE OR ONE WEEK POST-OP BECAUSE SURGEON SUSPECTED AN INFECTION (NOT RELATED TO THE HARDWARE). SINCE WE WERE GOING TO HAVE THE INCISION OPENED, THE SURGEON DECIDED TO RETIGHTEN THE SCREWS. ALMOST ALL OF THEM WERE VERY LOOSE. THERE WAS NO PATIENT CONSEQUENCE. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 9162986 ↗InjuryOct 7, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT WAS RETURNED TO THE OR ONE WEEK POST-OP BECAUSE SURGEON SUSPECTED AN INFECTION (NOT RELATED TO THE HARDWARE). SINCE WE WERE GOING TO HAVE THE INCISION OPENED, THE SURGEON DECIDED TO RETIGHTEN THE SCREWS. ALMOST ALL OF THEM WERE VERY LOOSE. THERE WAS NO PATIENT CONSEQUENCE. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 9162778 ↗InjuryOct 7, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT WAS RETURNED TO THE OR ONE WEEK POST-OP BECAUSE SURGEON SUSPECTED AN INFECTION (NOT RELATED TO THE HARDWARE). SINCE WE WERE GOING TO HAVE THE INCISION OPENED, THE SURGEON DECIDED TO RETIGHTEN THE SCREWS. ALMOST ALL OF THEM WERE VERY LOOSE. THERE WAS NO PATIENT CONSEQUENCE. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 9162706 ↗InjuryOct 7, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT WAS RETURNED TO THE OR ONE WEEK POST-OP BECAUSE SURGEON SUSPECTED AN INFECTION (NOT RELATED TO THE HARDWARE). SINCE WE WERE GOING TO HAVE THE INCISION OPENED, THE SURGEON DECIDED TO RETIGHTEN THE SCREWS. ALMOST ALL OF THEM WERE VERY LOOSE. THERE WAS NO PATIENT CONSEQUENCE. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 9161745 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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