EXPEDIUM 179732640Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034073866), received between Mar 25, 2022 and Feb 14, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (1 report).

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.

• InjuryFeb 14, 2024Migration; Migration

  IT WAS REPORTED THE PATIENT HAD A SPINE CONSTRUCT IMPLANTED (B)(6) 2023 FROM T10 TO PELVIS. THE PATIENT WAS IMPLANTED WITH 2 EXPEDIUM RODS, AN UNKNOWN NUMBER VIPER AND EXPEDIUM SCREWS, AND TWO PELVIC SCREWS. PATIENT WAS EXPERIENCING PAIN AND HAD A FOLLOW UP (B)(6) 2023. DURING THE FOLLOW UP IMAGES IDENTIFIED 2 BROKEN RODS AND AN UNKNOWN NUMBER OF MIGRATED SCREWS. THE PATIENT WILL BE HAVING A REVISION SURGERY ON (B)(6) 2024. THIS REPORT IS FOR ONE (1) UNK - MONO/POLYAXIAL SCREWS: VIPER THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 18703372 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS WAS COMPLETED ON (B)(6), 2022. AFTER THE SURGERY, ON (B)(6), 2023, AN INFECTION WAS CONFIRMED ON CONCAVE SIDE. REVISION SURGERY OCCURRED ON (B)(6), 2023. DURING THE REVISION, THE SET SCREWS ON T2·3·4·5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT BY THE T-SAW. THE RODS WERE REMOVED. FOUR OF THE UNIPLANAR SCREWS (5.0 DIAMETER 30MM LONG) ON THE LEFT T2-T5 WERE REMOVED. THE AFFECTED AREA WAS WASHED. THE HOOK WAS PLACED ON T2 (WIDE BLADE/THROAT 10). SIDE-SIDE CONNECTOR INSTALLED AT THE UPPER END OF T5. TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. THIS REPORT IS FOR ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 X 6 X 40MM FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18504212 ↗
• MalfunctionAug 18, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED DURING A CORRECTION OF LUMBAR THORACIC DEFORMITY SURGERY ON (B)(6) 2023, THE SCREW DOES NOT SCREW INTO THE STUNNER. IT IS MARKED AN EXTENDED TABLET SCREW 6X40 OF THE EXPEDIUM. IT DID NOT FIT IN ANY OF THE SCREWDRIVERS. THIS IS FOR ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 X 6 X 40MM FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17572747 ↗
• MalfunctionMar 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A PROCEDURE HAVING THE SCREW IN QUESTION, WAS NOT ABLE TO BE ATTACHED STRAIGHT TO THE SCREWDRIVER. AFTER REPLACING THE SCREW HAD NO FURTHER ISSUE IN CONNECTING TO THE SCREWDRIVER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS REPORT IS FOR ONE (1) SI POLYAXL EXT TAB 6 X 40MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905071 ↗