EXPEDIUM 179702645Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034064888), received between Nov 21, 2017 and Jun 6, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration” (4 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN TUNISIA AS FOLLOWS: IT WAS REPORTED THAT THE FIRST PROCEDURE WAS ON (B)(6) 2023. 6 SCREWS SYNTHES EXPEDIUM 5.5 WAS IMPLANTED DURING LUMBAR SPINE PROCEDURE. THE SECOND PROCEDURE, (B)(6) 2023 ( IT WAS REVISION) BECAUSE 4 AMONG THE 6 SCREWS CAME OFF. THERE WERE ADVERSE CONSEQUENCES BECAUSE THE PATIENT GOT SECOND SURGERY BECAUSE OF THIS INCIDENT. THIS REPORT IS FOR ONE (1) MONOAXIAL SCREW 6 X 45MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 17071230 ↗
• InjuryJun 6, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN TUNISIA AS FOLLOWS: IT WAS REPORTED THAT THE FIRST PROCEDURE WAS ON (B)(6) 2023. 6 SCREWS SYNTHES EXPEDIUM 5.5 WAS IMPLANTED DURING LUMBAR SPINE PROCEDURE. THE SECOND PROCEDURE, (B)(6) 2023 (IT WAS REVISION) BECAUSE 4 AMONG THE 6 SCREWS CAME OFF. THERE WERE ADVERSE CONSEQUENCES BECAUSE THE PATIENT GOT SECOND SURGERY BECAUSE OF THIS INCIDENT. THIS REPORT IS FOR ONE (1) MONOAXIAL SCREW 6 X 45MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 17071220 ↗
• InjuryJun 6, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN TUNISIA AS FOLLOWS: IT WAS REPORTED THAT THE FIRST PROCEDURE WAS ON (B)(6) 2023. 6 SCREWS SYNTHES EXPEDIUM 5.5 WAS IMPLANTED DURING LUMBAR SPINE PROCEDURE. THE SECOND PROCEDURE, (B)(6) 2023 ( IT WAS REVISION) BECAUSE 4 AMONG THE 6 SCREWS CAME OFF. THERE WERE ADVERSE CONSEQUENCES BECAUSE THE PATIENT GOT SECOND SURGERY BECAUSE OF THIS INCIDENT. THIS REPORT IS FOR ONE (1) MONOAXIAL SCREW 6 X 45MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 17071219 ↗
• InjuryJun 6, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN TUNISIA AS FOLLOWS: IT WAS REPORTED THAT THE FIRST PROCEDURE WAS ON (B)(6) 2023. 6 SCREWS SYNTHES EXPEDIUM 5.5 WAS IMPLANTED DURING LUMBAR SPINE PROCEDURE. THE SECOND PROCEDURE, (B)(6) 2023 ( IT WAS REVISION) BECAUSE 4 AMONG THE 6 SCREWS CAME OFF. THERE WERE ADVERSE CONSEQUENCES BECAUSE THE PATIENT GOT SECOND SURGERY BECAUSE OF THIS INCIDENT. THIS REPORT IS FOR ONE (1) MONOAXIAL SCREW 6 X 45MM THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 17071218 ↗
• InjuryAug 8, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PROCEDURE/SURGERY NAME: AIS SCOLIOSIS CORRECTION / SPINE. PROCEDURE/SURGERY DATE : (B)(6) 2018. DESCRIBE EVENT: POST OPERATIVE, THE MOST CAUDAL SETSCREW ON THE LEFT SIDE CAME LOOSE OUT OF THE MONOAXIAL SCREW. DUE TO THIS, THE ROD WAS LOOSED OUT OF THE CAUDAL PART OF THE CONSTRUCT. SURGEON REMOVED TOTAL CONSTRUCT IN A REVISION SURGERY WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE ? PRIMARY SURGERY WAS ON (B)(6) 2013. POST OP PROBLEM OCCURRED AND ON (B)(6) 2018 THE REVISION SURGERY TOOK PLACE. HOW LONG WAS THE PROCEDURE PROLONGED AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE(MINUTES)? NO DELAY. PROBLEM OCCURED POST OP.

  Patient problems: Spinal Column Injury

  MAUDE report 7762323 ↗
• InjuryNov 21, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  ON (B)(4) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT SET SCREWS (PART#: UNK) FIXED AT CAUDAL END WERE LOOSENED AND THAT RODS HAD MOVED IN UPPER POSITION, RESULTING IN LOSS OF THE CORRECTIVE FORCE. THE SURGEON DECIDED TO CONDUCT RE-OPERATION NEXT WEEK BECAUSE SUCH LOOSENED SET SCREWS MIGHT CONTACT THE HEART OF THE PATIENT. HE WILL USE NON-J&J REPLACEMENTS AT THE RE-OPERATION SCHEDULED NEXT WEEK.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7049555 ↗