EXPEDIUM TOP NOTCH 179771655Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034077826), received between Feb 12, 2021 and Feb 12, 2021 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K092626, 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.

• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE SURGEON WAS EXTENDING AN EXISTING CONSTRUCT THAT HAD BEEN PLACED IN LEVELS L4-S1 BACK IN 2014. UPON REMOVING THE CROSSLINK, ATTEMPTED TO PLACE THE RODE TO ROD CONNECTOR TO THE EXISTING CONSTRUCT. AS DROVE THE SET SCREW INTO PLACE, A SLIGHT CLICKING SOUND WAS NOTICED AND THAT THE FINAL TIGHTENER LOST RESISTANCE. UPON INSPECTION, IT WAS NOTICED THAT THE IMPLANT HAD CRACKED. HE REMOVED THE IMPLANT AND SUCCESSFULLY REPLACED IT WITH ANOTHER WITHOUT ANY ISSUE. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT AND THE LOSS OF TIME IN THE SURGERY WAS LESS THAN 5 MINUTES. THE REMAINDER OF THE REVISION SURGERY AND TLIF SPACER PLACEMENT WENT FORWARD WITHOUT INCIDENT OR ANY HARM TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN SETSCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN TRANS CONNECTOR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) CONN O/O SD TOP NOTCH 6.35X5.5. THIS IS REPORT 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11323534 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092626, 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