EXPEDIUM 279712830Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705034199092), received between Nov 30, 2020 and Nov 3, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT A VERY COMPLICATED PATIENT HAD VERY HARD BONE THAT BROKE SEVERAL INSTRUMENTS DURING THE PROCEDURE. THERE WERE NO SURGERY DELAYED DUE TO THE REPORTED EVENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452898 ↗
• MalfunctionAug 11, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ALL 3 X EXPEDIUM 5.5 MONO AXIAL SCREW DRIVERS ARE WORN AND UNUSABLE (FAIL TO RETAIN/HOLD SCREW SECURELY). THE PROCEDURE WAS EXTENDED 5 MINUTES DUE TO THE FAILURE. THE CASE WAS FINISHED WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771814 ↗
• MalfunctionAug 11, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ALL 3 X EXPEDIUM 5.5 MONO AXIAL SCREW DRIVERS ARE WORN AND UNUSABLE (FAIL TO RETAIN/HOLD SCREW SECURELY). THE PROCEDURE WAS EXTENDED 5 MINUTES DUE TO THE FAILURE. THE CASE WAS FINISHED WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771706 ↗
• MalfunctionAug 11, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ALL 3 X EXPEDIUM 5.5 MONO AXIAL SCREW DRIVERS ARE WORN AND UNUSABLE (FAIL TO RETAIN/HOLD SCREW SECURELY). THE PROCEDURE WAS EXTENDED 5 MINUTES DUE TO THE FAILURE. THE CASE WAS FINISHED WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771675 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT THE SPRING OF THE INSERTER CAME OUT SO INSERTER WAS NOT USABLE. THERE WAS AN EXTRA KIT WITH ANOTHER INSERTER, SO CASE WAS NOT COMPROMISED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327247 ↗
• MalfunctionJan 9, 2023Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE DURING POST CASE INSPECTION IT WAS NOTICED THAT THE SPRING ON THE DEVICE HAD BROKEN. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) MONOAXIAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120604 ↗
• MalfunctionOct 17, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS NO LONGER POSSIBLE TO FIX A SCREW ON THE INSTRUMENT. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM MONOAXIAL SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15617236 ↗
• MalfunctionOct 17, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS NO LONGER POSSIBLE TO FIX A SCREW ON THE INSTRUMENT. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM MONOAXIAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15617003 ↗
• MalfunctionApr 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: MALFUNCTION WAS REPORTED DURING A PROCEDURE. SCREW WAS NOT ATTACHING SECURELY ONTO THE HANDLE. NO PATIENT DELAYS OR INJURIES WERE REPORTED. CONCOMITANT DEVICE REPORTED: UNK - SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) MONOAXIAL SCREWDRIVER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14239729 ↗
• MalfunctionJun 8, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE SCREW WOULD NOT MOUNT ONTO THE DRIVER PROPERLY. IT WAS DIFFICULT TO REMOVE THE SCREWS FROM THE DRIVER AFTER INSERTION. UPON INSPECTION OF THE DRIVERS, THE DRIVERS APPEARED TO BE DEFORMED. A SPARE DRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THERE WAS NO IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM MONOAXIAL SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957464 ↗
• MalfunctionJun 8, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE SCREW WOULD NOT MOUNT ONTO THE DRIVER PROPERLY. IT WAS DIFFICULT TO REMOVE THE SCREWS FROM THE DRIVER AFTER INSERTION. UPON INSPECTION OF THE DRIVERS, THE DRIVERS APPEARED TO BE DEFORMED. A SPARE DRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THERE WAS NO IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM MONOAXIAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957349 ↗
• MalfunctionFeb 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE MONOAXIAL SCREWDRIVER DID NOT RETAIN THE SCREW PROPERLY. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL IMPACT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE INSTRUMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) MONOAXIAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386139 ↗
• MalfunctionNov 30, 2020Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE HOLDING SPRING/CLIP ON THE MONO AXIAL SCREWDRIVER IS LOOSE AND NOT HOLDING THE SCREWS PROPERLY. THE EVENT MUST HAVE HAPPENED PRE- OP AS THE SPRING CLIP WAS NOTICED TO BE OUT OF ALIGNMENT WHEN WE OPENED THE SET. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY OPENING ANOTHER TRAY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) MONOAXIAL SCREWDRIVER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10921011 ↗