EXPEDIUM 286210130Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705034211121), received between Oct 11, 2017 and Sep 11, 2026 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (17 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741412 ↗
• MalfunctionSep 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741202 ↗
• MalfunctionAug 28, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50503233 ↗
• MalfunctionAug 27, 2026Break

  It was reported that X25 FINAL TIGHTENER, VERSE X25 INSERTER/TIGHTENER, and FINAL TIGHTENER X20 chipped too quickly and broke during use, including reports that tips broke inside the patient. The event was identified pre-operatively/intraoperatively during use. No patient harm or significant delay was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479596 ↗
• MalfunctionNov 10, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN USING THE X20 FINAL TIGHTENER DRIVER, IT WAS OBSERVED TO BE STRIPPED. THERE WAS NO DELAY IN SURGICAL TIME. THERE WAS NO PATIENT COMPLICATIONS, AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511644 ↗
• MalfunctionOct 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS ARE WORN OUT FROM USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20442649 ↗
• MalfunctionJun 20, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE SURGERY THE TIP OF A TORQUE OF THE EXPEDIUM 4.5 SYSTEM BROKE AND REMAINED IN THE INNER PART THAT WAS USED ON THE PATIENT. FORTUNATELY, THIS DID NOT CAUSE HARM TO THE PATIENT. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM FINAL TIGHTENER X20. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19573897 ↗
• MalfunctionMay 12, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE TIGHTENER WAS STRIPPED DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) FINAL TIGHTENER X20. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16922517 ↗
• MalfunctionApr 16, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIGHTENER WAS STRIPPED DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) FINAL TIGHTENER X20. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748636 ↗
• MalfunctionJan 3, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVER TIPS HAD BECOME WORN. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM FINAL TIGHTENER X20. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085229 ↗
• MalfunctionJan 3, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVER TIPS HAD BECOME WORN. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM FINAL TIGHTENER X20. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085226 ↗
• MalfunctionDec 16, 2022Material Twisted/Bent; Material Twisted/Bent

  NO DELAY INDICATED OR NO HARM. NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996506 ↗
• MalfunctionNov 10, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING PRE-CASE INSPECTION THE HEX TIP ON THE ITEMS HAD BECOME STRIPPED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM FINAL TIGHTENER X20. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15771010 ↗
• MalfunctionNov 10, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING PRE-CASE INSPECTION THE HEX TIP ON THE ITEMS HAD BECOME STRIPPED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM FINAL TIGHTENER X20. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15771003 ↗
• MalfunctionNov 10, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING PRE-CASE INSPECTION THE HEX TIP ON THE ITEMS HAD BECOME STRIPPED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM FINAL TIGHTENER X20. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770985 ↗
• MalfunctionNov 10, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING PRE-CASE INSPECTION THE HEX TIP ON THE ITEMS HAD BECOME STRIPPED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM FINAL TIGHTENER X20. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770925 ↗
• MalfunctionOct 4, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PEDIATRIC ORTHOPEDIC CASE, THE LABELED PART OF THE INSTRUMENT THAT CORRESPONDS TO THE FINAL ADJUSTMENT OF THE CLOSING SCREWS HAD A DEFORMED RELIEF FOR X20 RECESS, MAKING IT DIFFICULT TO TIGHTEN THE FINAL SYSTEM. IT TENDED TO SLIP IN THE RECESSES OF THE CLOSING SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY OTHER ISSUES. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM FINAL TIGHTENER X20. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15539490 ↗
• MalfunctionSep 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022 A PART OF THE SCREWDRIVER IN QUESTION WAS MISSING, PREVENTING THE SURGEON FROM LOCKING THE SYSTEM PROPERLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM FINAL TIGHTENER X20. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15381479 ↗
• MalfunctionMay 12, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2022, THE SURGEON WAS PERFORMING FINAL TIGHTENING ON AN EXPEDIUM 4.5 SET SCREW AND HE STRIPPED BOTH FINAL TORQUE DEVICES AT THE DISTAL END TIP. ACCORDING TO THE REPORT, THE SURGEON WAS ABLE TO COMPLETE THE CASE WITH THE LEAST DAMAGED DRIVER WHICH ALSO HAD STRIPPED THREADS AT THE DISTAL END TIP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14374039 ↗
• MalfunctionMay 12, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2022, THE SURGEON WAS PERFORMING FINAL TIGHTENING ON AN EXPEDIUM 4.5 SET SCREW AND HE STRIPPED BOTH FINAL TORQUE DEVICES AT THE DISTAL END TIP. ACCORDING TO THE REPORT, THE SURGEON WAS ABLE TO COMPLETE THE CASE WITH THE LEAST DAMAGED DRIVER WHICH ALSO HAD STRIPPED THREADS AT THE DISTAL END TIP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14374011 ↗
• MalfunctionMar 5, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SPINE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, WHEN SURGEON WAS DOING THE FINAL TIGHTENING ON THE EXPEDIUM 4.5 CAPS WITH A FINAL TIGHTENER, THE DISTAL TIP OF IT STRIPPED. THE SCREWDRIVER WAS IMPROPERLY INSERTED, THEREFORE THE THREADS GOT DAMAGED. ANOTHER SPARE SCREWDRIVER WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO SURGICAL DELAY AND NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) FINAL TIGHTENER X20. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11424084 ↗
• MalfunctionFeb 11, 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, THE PATIENT UNDERWENT FOR THE SPINAL FUSION WITH THE EXPEDIUM. THE PATIENT HAD VERY HARD BONE AND CONSEQUENTLY THE BALL TIP FEELER WERE BOTH SIGNIFICANTLY BENT ALONG WITH THE FINAL TORQUE DRIVER WAS STRIPPED. THERE WAS NO FRAGMENT GENERATED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) UNK - PLATES. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11316048 ↗
• MalfunctionJan 13, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A LENGTHENING PROCEDURE ON (B)(6) 2020, THE SURGEON WAS FINAL TIGHTENING THE SET SCREWS, AND NOTICED THAT THE SCREWDRIVER SHAFT WAS STARTING TO STRIP AT THE DISTAL END TIP. THE CASE WAS COMPLETED WITH THIS SCREWDRIVER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT WAS NOT IMPACTED. THIS REPORT IS FOR AN EXPEDIUM FINAL TIGHTENER X20. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11166517 ↗
• MalfunctionJun 19, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING THE FINAL TIGHTENING OF A SPINE CASE THE T20 EXPEDIUM 5.5 FINAL TIGHTENER WAS SKIPPED. IT WAS FOUND STRIPPED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) FINAL TIGHTENER X20. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10173964 ↗
• MalfunctionJun 19, 2018Material Deformation; Material Deformation

  DATE J&J BECAME AWARE: (B)(4) 2018. DATE OF EVENT: (B)(6) 2018. NAME OF REPORTER: (B)(6). HOSPITAL NAME: (B)(6) HOSPITAL. PRODUCT NAME: 4.5 EXPEDIUM FINAL TIGHTENER DRIVER X 2. PRODUCT CODE: 2862-10-130 X 2. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. EVENT OUTCOME/HOW WAS IT MANAGED? OPENED THE OTHER SET TO USE THE INSTRUMENTS FROM THAT ONE. WAS THERE A PATIENT IMPACT OR WAS THE PROCEDURE EXTENDED GREATER THAN 30 MINUTES DUE TO THE FAILURE? NO, NOT GREATER. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? THEY WERE SENT AWAY TO BE STERILISED. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: SURGEON WAS FINAL TIGHTENING THE SCREWS WHICH IS THE LAST IMPORTANT STEP TO SECURING THE SCREWS INTO POSITION AND THE DRIVERS WERE ROUNDED OFF SO UNABLE TO GRIP THE SCREWS HEAD.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7615041 ↗