EXPEDIUM 179788645Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034081403), received between Sep 29, 2017 and Mar 30, 2021 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A ROUTINE SCOLIOSIS DEFORMITY CORRECTION SURGERY, THE SURGEON NOTICED THAT IT WAS BECOMING INCREASINGLY DIFFICULT TO SEAT THE ROD INSIDE THE HEAD OF THE EXPEDIUM 6 X 45MM UNIPLANAR SCREW. UPON FURTHER INVESTIGATION, THE SURGEON NOTICED THAT THE INNER COLLAR OF THE SCREW HAD POPPED UPWARDS AND WOULD NOT ALLOW THE ROD TO SIT PROPERLY INSIDE THE HEAD OF THE UNIPLANAR SCREW. THE SCREW HAD ALSO LOST ITS UNIPLANAR CAPABILITIES DUE TO THE NEW POSITION OF THE COLLAR. THE SCREW WAS REMOVED, AND A NEW SCREW WAS INSERTED IN ITS PLACE. THE SCREW HAD INITIALLY BEEN EASILY INSERTED ONTO THE POLYAXIAL SCREWDRIVER AND INSERTED ROUTINELY INTO THE PEDICLE WITHOUT ISSUE. IT WAS ONLY ON CORRECTION AND PLACEMENT OF THE ROD THAT THE SURGEON NOTICED THE COLLAR OF THE SCREW HAD POPPED UPWARDS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIVE (5) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN EXPEDIUM TITANIUM (TI) SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11588512 ↗
• InjuryOct 18, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  REVISION FUSION: (B)(6) HOSPITAL, (B)(6) 2019. PRIMARY IMPLANT DATE: (B)(6) 2018. THREAD WAS DAMAGED WHEN REDUCING ROD TO SCREW HEAD USING FLEX CLIP REDUCER. REPLACED THE SCREW WITH A POLYAXIAL SCREW. NO AE REPORTED. 5-10 MINUTES DELAY IN THE SURGERY.

  Patient problems: Not Applicable

  MAUDE report 9209100 ↗
• InjuryAug 16, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  REVISION FUSION: (B)(6), (B)(6) HOSPITAL, (B)(6) 2019. PRIMARY IMPLANT DATE: (B)(6) 2018. REVISION FOR DISLODGED RODS. SET SCREWS WERE NO LONGER IN SCREW HEADS RIGHT SIDE ROD NO LONGER STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY ONE). THIS COMPLAINT INVOLVES 11 (ELEVEN) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8902887 ↗
• InjuryAug 16, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  REVISION FUSION: (B)(6) HOSPITAL, (B)(6) 2019. PRIMARY IMPLANT DATE: (B)(6) 2018. REVISION FOR DISLODGED RODS. SET SCREWS WERE NO LONGER IN SCREW HEADS RIGHT SIDE ROD NO LONGER STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY ONE). THIS COMPLAINT INVOLVES 11 (ELEVEN) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8902843 ↗
• InjuryAug 16, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  REVISION FUSION: (B)(6) HOSPITAL, (B)(6) 2019. PRIMARY IMPLANT DATE: (B)(6) 2018. REVISION FOR DISLODGED RODS. SET SCREWS WERE NO LONGER IN SCREW HEADS RIGHT SIDE ROD NO LONGER STABLE CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY ONE). THIS COMPLAINT INVOLVES 11 (ELEVEN) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8902362 ↗
• MalfunctionSep 29, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2017, SURGERY FOR IDIOPATHIC SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE PARTS TO FIX WERE T8 -L3. DURING THE SURGERY, THE FOLLOWING ISSUES WERE CONFIRMED. THE SURGEON COMPLETED THE CORRECTION OF SCOLIOSIS AND VERTEBRAL ROTATION USING THE SCREW (PART#: 179788645, LOT#: TBLFR). AT THE TIME OF FINAL TIGHTENING, HE COULD NOT INSERT A COUNTER (PAR# & LOT#: UNK) TO THIS SCREW BECAUSE THE SCREW DID NOT ACCEPT THE COUNTER. HE SUCCESSFULLY REMOVED THE SCREW IN QUESTION AND THEN INSERTED A NEW SCREW TO THE LOCATION WHERE THE SCREW IN QUESTION HAD BEEN INSERTED. THE SURGERY WAS COMPLETED WITH A 10-MINUTE DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS EVENT WAS POSTOPERATIVELY REPORTED TO OUR SALES PERSON AND THE REPORTED PRODUCT WAS ALREADY COLLECTED. NO FURTHER INFORMATION HAS BEEN PROVIDED FROM THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6905506 ↗