EXPEDIUM 179978600Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034092355), received between Nov 15, 2021 and Nov 19, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K090230, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE EXP 6.35 COCR ROD W/HEX ENDS 6 WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) NUMBER OF DEVICES. THIS REPORT IS FOR (1) EXP 6.35 COCR ROD W/HEX ENDS 6. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848455 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT (B)(6). THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ROD, STRAIGHT (WITH HEX ENDS) 6.35 X 600MM. THIS IS REPORT 11 OF 13 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12815718 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT (B)(6). THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ROD, STRAIGHT (WITH HEX ENDS) 6.35 X 600MM. THIS IS REPORT 9 OF 13 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12815640 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT (B)(4). THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ROD, STRAIGHT (WITH HEX ENDS) 6.35 X 600MM. THIS IS REPORT 4 OF 13 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12815514 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090230, 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