EXPEDIUM 186112025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034104737), received between Jan 3, 2019 and Jan 3, 2019 — 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 (K071495, 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 18, 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.

• InjuryJan 3, 2019Migration; Migration

  IT WAS REPORTED THAT DR. (B)(6) DID THE PRIMARY FUSION ON OCTOBER 1ST. THIS FUSION INVOLVED EXPEDIUM 4.5 IN COMBINATION WITH THE SPECIAL ACCESS SYSTEM TROLLEY. DR, (B)(6) MENTIONED THAT HE OVERCORRECTED THE SCOLIOSIS AND THERE WAS A PROXIMAL PULLOUT OF THE CONSTRUCT. BASICALLY THE FIRST SET SCREW ON THE LEFT SIDE OF THE CONSTRUCT AT T3 COMPLETELY CAME OFF AND CONSEQUENTLY THE SCREW AT T4 COMPLETELY PULLED OUT OF THE PEDICLE AS THERE WAS TREMENDOUS STRESS ON THAT SCREW. THIS PARTICULAR SCREW WAS REPLACED WITH A NEW 4.35X30MM AND A NEW ROD AND NEW SET SCREW WAS PLACE ON THE FIRST SCREW. THE PATIENT WAS AFFECTED BY THIS REVISION, INFO IS BELOW. NO REPLACEMENT IS NEEDED. I HAVE NOTHING FURTHER TO ADD. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION:THE PATIENT NEEDED REVISION SURGERY IN ORDER TO CORRECT THE POP OFF CAP AND PULLOUT SCREW. ACTION TAKEN FOR PROCEDURE:REVISION SURGERY. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Code Available

  MAUDE report 8212635 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071495, 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