EXPEDIUM 179798300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034083070), received between Oct 1, 2020 and Oct 1, 2020 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K033901, K111136); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2020Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH AN INSTRUMENTATION FROM TH11 TO L1 WITH USS MIS FEW YEARS AGO. ON (B)(6) 2020 THE INSTRUMENTATION WAS CONTINUED FROM L2 TO S1. ON (B)(6) 2020 THE PATIENT FELL WHILE EXITING THE HOSPITAL BED. X-RAYS TAKEN REVEALED THAT BOTH EXPEDIUM RODS HAVE BEEN DISLOCATED. FURTHERMORE IT WAS SUSPECTED THAT BOTH EXPEDIUM INNIES IN S1 HAD COME LOOSE. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 AND INNIES AT L4/L5 AND S1 WERE REMOVED FROM BOTH SIDES OF THE RODS AND REPLACED. THE SAME ROD WAS USED. THE 6.0 SCREWS IN S1 WERE REPLACED WITH 7.0 SCREWS. IT IS UNKNOWN IF 2X VIPER CFX 6,0, OR 2X VIPER 6,0 HAVE BEEN REMOVED. PATIENT OUTCOME IS REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED: VIPER CFX 6.0 (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2); VIPER 6.0 (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2); SINGLE INNIE INSERTER (PART# 279702000, LOT# UNKNOWN, QUANTITY UNKNOWN); SINGLE-INNER SETSCREW (PART # 179702000, LOT # AVCFFH, QUANTITY 3); SINGLE-INNER SETSCREW (PART # 179702000, LOT # 257617, QUANTITY 1); SINGLE-INNER SETSCREW (PART # 179702000, LOT # UNKNOWN, QUANTITY 2); ROD (PART # UNK

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Injury; No Code Available

  MAUDE report 10614094 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033901, K111136. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2015 · Apr 21, 2015 · Terminated
  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467