EXPEDIUM 299704115Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034467238), received between Sep 26, 2017 and Jan 25, 2023 — classified as 1 injury, 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE SURGEON WAS USING THE FINDER WHEN THE TIP SNAPPED OFF. ANOTHER SET IN THE HOSPITAL WAS USED. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) LUMBAR PEDICLE PROBE, ST. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16242341 ↗
• InjurySep 26, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE EXPEDIUM VERSE PEDICLE PROBE (STRAIGHT LUMBAR) BROKE OFF 10 MM INSIDE THE PATIENTS VERTEBRAL BODY. BROKEN FRAGMENTS WHERE GENERATED, IT WAS DIFFICULT TO REMOVED THAT'S WHY IT WAS RETAINED AND KEPT IN THE BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT STATUS WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9125372 ↗
• MalfunctionOct 19, 2017Break; Break

  PROBE END HAS TWISTED AND A PIECE HAS BROKEN OFF. BROKEN PIECE WAS NOT RETURNED. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6962970 ↗
• MalfunctionSep 26, 2017Break; Break

  L5/S1 PLIF. WHILE USING 299704115 TO CREATE THE S1 (RIGHT SIDE) PEDICLE SCREW TRAJECTORY THE PROBE WAS INSERTED BY HAND AND THEN ADVANCED WITH A MALLET. IT WAS THEN ROTATED IN THE PATIENT AND THE TIP SNAPPED OFF. THE TIP STILL REMAINS IN THE PATIENTS SACRUM AS THE SURGEON DEEMED IT TO DIFFICULT TO RETRIEVE. THE 299704105 WAS THEN USED INSTEAD AND THE PROCEDURE WAS COMPLETED TO THE SURGEONS SATISFACTION. 2 MINUTE DELAY TO PROCEDURE. AE TO PATIENT: PART OF 299704115 REMAINS IN THE PATIENTS SACRUM. 'PRODUCT DISCARDED' HAS BEEN SELECTED FOR PRODUCT STATUS IN THIS INSTANCE AS THERE IS NO APPROPRIATE STATUS AVAILABLE TO REPRESENT THE FOLLOWING LOCAL PROCESS: INSTRUMENT WILL BE SENT TO LOCAL ENGINEERING FOR ASSESSMENT OF WEAR AND TEAR. IF 'WEAR AND TEAR' IS ASSIGNED, A COPY OF THE LOCAL ASSESSMENT WILL BE PROVIDED TO THE MANUFACTURER FOR THEIR RECORD AND CASE CLOSURE. IN THE CASE WEAR AND TEAR CANNOT BE ASSIGNED BY THE ENGINEER, THE PRODUCT WILL BE RETURNED TO THE MANUFACTURER AS A 'PRODUCT COMPLAINT' FOR INVESTIGATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6894918 ↗