EXPEDIUM 279702120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034198507), received between Mar 20, 2020 and Jun 22, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT WHILE USING THE TEAR DROP HANDLE AND SCREW DRIVER SHAFT TO UNDO A PEDICLE SCREW AND THEY, HANDLE AND SHAFT BECAME WEDGED TOGETHER. UNABLE TO SEPARATE POST OPERATIVELY, THE "BUTTON" ON THE HANDLE APPEARED STUCK AND WOULD NOT RELEASE THE SCREWDRIVER SHAFT. A SECOND HANDLE AND SCREWDRIVER SHAFT WERE USED. SURGERY WAS NOT DELAYED DUE TO THE EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) TEAR-DROP HANDLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14777654 ↗
• MalfunctionOct 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE THAT THE X25 FINAL TIGHTENER X2 TIP WAS WORN AND TWISTED AND THE BLUE PALM HANDLE X1 NO LONGER CONNECTS TO THE INSTRUMENT SHAFTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ALTERNATE INSTRUMENTS AND NO DELAY. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM TEAR-DROP HANDLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638983 ↗
• MalfunctionApr 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR SPINAL FUSION. THE SCRUB NURSE PREOPERATIVELY TRIED TO CONNECT THE HEAD ADJUSTER TO A TEARDROP HANDLE (279702120), WHICH FAILED. ALSO, TRIED TO CONNECT THE HEAD ADJUSTER WITH ANOTHER COUNTERPART HANDLES SUCH AS 279702140, 286715300, AND 299704135, WHICH ALL WAS FAILED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT WITHOUT SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) TEAR-DROP HANDLE. THIS REPORT IS 2 OF 5 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755983 ↗
• MalfunctionNov 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE HANDLE IS "STICKING" WHEN THE SCREWDRIVER SHAFT IS INSERTED, AND IT IS VERY DIFFICULT TO DISCONNECT. THIS WAS NOTED AFTER THE OPERATION WHEN THE INSTRUMENT WAS DISS-ASSEMBLED. THIS REPORT IS FOR ONE (1) TEAR-DROP HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10862314 ↗
• MalfunctionMar 20, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES REPORTED: MMSI HEAD ADJUSTER (PART# 279712350, LOT# NW193658, QUANTITY# 1).

  Patient problems: No Patient Involvement

  MAUDE report 9863050 ↗