EXPEDIUM 279702000Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705034198408), received between May 12, 2020 and May 29, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN PASSING THE INTERNAL SCREWS AND USING THE SCREWDRIVERS, IT WAS EVIDENT THAT ONE OF THE SCREWDRIVERS DID NOT GRIP THE NUT WELL AND WHEN DETAILING IT A LITTLE MORE IT WAS OBSERVED TOGETHER WITH THE SPECIALIST THAT THE TIP OF THIS SCREWDRIVER WAS IN VERY POOR CONDITION, IT WAS THEN SOLVED WITH ANOTHER SCREWDRIVER OF THE SAME REFERENCE AND CHARACTERISTICS THAT ALSO COMES INSIDE THE EQUIPMENT. IN ADDITION TO THIS, WHEN PERFORMING THE COUNTER TORQUE WITH THE SCREWDRIVERS IT WAS PRESENTED THAT NEITHER OF THE TWO THE TIPS FIT WELL IN THE NUT, SO THEY ROLLED AND DID NOT APPLY THE PROPER TORQUE (THEY DID NOT GRIP THE NUT WELL). WITH THESE SCREWDRIVERS THERE WAS NO WAY TO FIND A SOLUTION IN THIS REGARD BECAUSE THERE WERE NO MORE UNITS OF THE SAME REFERENCE AND THE DOCTOR HAD TO ADJUST THE SCREWS WITH ANOTHER REFERENCE WHICH PREVIOUSLY, IT WAS MENTIONED THAT IT WAS IN GOOD CONDITION AND WAS THE ONLY FUNCTIONAL SCREWDRIVER THAT WAS AVAILABLE, THUS MANAGING TO COMPLETE THE SURGERY SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104379 ↗
• MalfunctionJan 6, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FINAL TIGHTENER STRIPPED DURING THE CASE WHEN TRYING TO REMOVE A SET SCREW THAT WAS ALREADY TORQUED OUT. ADDITIONALLY, THE SURGEON BROKE A SET SCREW INSERTER WHEN TRYING TO TIGHT A CLAW CONNECTOR. THE BLACK HANDLE STARTED SPINNING SO THE SET SCREW ON THE CLAW CONNECTOR WOULD NOT TIGHTEN. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078089 ↗
• MalfunctionFeb 1, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHILE AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF THE INNER INSERTER BROKE. WHEN INSERTING THE LOCKING SCREW, THE TIP BECAME DETACHED FROM THE STEM. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) SINGLE INNIE INSERTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624530 ↗
• MalfunctionJun 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, TWO (2) X25 INSERTER WERE NOT SELF RETAINING ANYMORE AND THEREFOR THE INNER SET SCREW WERE FALLING IN THE OPERATING AREA. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH SIMILAR PRODUCT. THERE WAS 10-15 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) SINGLE INNIE INSERTER THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17150497 ↗
• MalfunctionJun 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, TWO (2) X25 INSERTER WERE NOT SELF RETAINING ANYMORE AND THEREFOR THE INNER SET SCREW WERE FALLING IN THE OPERATING AREA. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH SIMILAR PRODUCT. THERE WAS 10-15 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) SINGLE INNIE INSERTER THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17150484 ↗
• MalfunctionAug 23, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE SCREWDRIVER BROKE DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCE, ALL PIECES WERE RECOVERED. THIS REPORT IS FOR ONE (1) SINGLE INNIE INSERTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280358 ↗
• MalfunctionAug 22, 2022Break; Break

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO BROKEN SCREWDRIVERS WERE FOUND IN AN ANCILLARY KIT. NO PATIENT INVOLVEMENT WAS REPORTED. . THIS REPORT IS FOR A EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15265513 ↗
• MalfunctionJun 29, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWEDEN AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT WHEN CLEANING INSTRUMENTS AT THE STERILE CENTER, IT WAS DISCOVERED THAT THE TIP OF INSTRUMENT SINGLE INNIE SCREWDRIVER FOR EXPEDIUM 5.5 IS NOT REALLY CLEAN. NO PATIENT WAS INVOLVED, HENCE NO NEGATIVE PATIENT IMPACT. NOR DOES IT AFFECT THE OPERATION TIME OR OTHER TIME WHEN IT WAS DISCOVERED DURING CLEANING. THIS REPORT IS FOR ONE (1) SINGLE INNIE INSERTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852857 ↗
• MalfunctionFeb 25, 2022Break; Device Slipped; Break; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE TIP OF THE SET SCREWDRIVER BROKE AND BECAME LOOSE, CAUSING IT TO SPIN FREELY IN THE SET SCREW RECESS. INSTEAD OF TIGHTENING THE SET SCREW INTO THE TULIP. NO SURGICAL DELAY REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5 THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13598827 ↗
• MalfunctionDec 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A PROCEDURE FOR THE LUMBAR VERTEBRAL FRACTURE WITH INSERTER HANDLE IN QUESTION. WHILE TIGHTENING THE ROD, THE INSERTER HANDLE WAS IDLING AND SET SCREW WAS NOT TIGHTENED EITHER. PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER HANDLE AND WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN SET SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SINGLE INNIE INSERTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078063 ↗
• MalfunctionNov 3, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE DISTAL PART OF THE INSERTER ROTATED WHICH PREVENTED THE ADJUSTMENT OF THE NUTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETE WITHOUT SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745924 ↗
• MalfunctionOct 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE HEX WAS DISINSERTED OF THE SHANK DURING NUT TIGHTENING. THERE WAS NO PATIENT HARM. SURGERY WAS COMPLETED WITHOUT ANY INCONVENIENCE. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572924 ↗
• MalfunctionDec 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING INSPECTION IT WAS NOTICED THAT THE TIP OF THE INSERTER FELL APART AND THE GOLDEN MARKING OF THE HEAD POSITIONER WAS NOT POSITIONED CORRECTLY. IT COULD NOT BE CONNECTED TO THE HANDLE. NO SURGICAL INVOLVEMENT. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936516 ↗
• MalfunctionNov 10, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON OCTOBER 15, 2020, THE TIP OF THE SCREWDRIVER WAS BROKEN. THERE WAS NO SURGICAL DELAY REPORTED. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) SINGLE INNIE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10818461 ↗
• MalfunctionOct 1, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE SINGLE INNIE INSERTER TIP, WITH WHICH THE SINGLE INNIES ARE PICKED UP HAS BROKEN OFF. NO PARTS REMAINED IN PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER AVAILABLE INSTRUMENT. NO SURGERY DELAY REPORTED. NO ADVERSE PATIENT HARM REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS REPORT IS FOR ONE (1) SINGLE INNIE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10616749 ↗
• MalfunctionAug 19, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT UNABLE TO CLEAN THE DISTAL END OF THE X25 INSERTER FOR INNIES BY FOLLOWING ALL CLEANING STEPS. IT DID NOT HAPPEN DURING THE PROCEDURE BUT STILL RISK FOR CONTAMINATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN INNIES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) MMSI DRIVER SHAFT FOR RED SCREW THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10428255 ↗
• MalfunctionJul 13, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE HOSPITAL WAS UNABLE TO CLEAN THE DISTAL END OF THE INSERTER FOR INNIES. SEVERAL CLEANING STEPS WERE PERFORMED MULTIPLE TIMES SUCH AS REWASHING, SOAKING, BRUSHING AND ULTRASONIC. A SAMPLE OF THE DEBRIS WAS TAKEN AND TESTED FOR PROTEIN AND RESULTS WERE NEGATIVE. CONCOMITANT DEVICE REPORTED: UNKNOWN INNIES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10263574 ↗
• MalfunctionMay 12, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: UNKNOWN INNIES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). APPROXIMATOR FC SLEEVE (PART# 279712580, LOT#NW238047, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10049082 ↗