EXPEDIUM 179761000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034077277), received between Apr 23, 2018 and Apr 23, 2018 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K092626, K111136, K142460); 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.

• InjuryApr 23, 2018Torn Material; Torn Material

  IT WAS REPORTED SCREWDRIVER TIP BROKE IN THE SCREW INTERFACE. WHEN THE SURGEON TRIED TO FINAL TIGHTEN SET SCREW ON THE ROD, THE SET SCREW STRIPPED AND BROKE. WE HAD TO SAW THE HEAD OFF THE SCREW AND THEN USE A UNIVERSAL REMOVAL SET AND A REVERSE THREADED DRIVER TO GET THE ILLIAC SCREW OUT.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7452233 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092626, K111136, K142460. 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