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EXPEDIUM 188112740Recalls & reported problems

Depuy Spine, LLC · EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 x 7 x 40mm · Class 2

All models of EXPEDIUM (29)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034146973), received between Aug 22, 2017 and Aug 22, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K041119, 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

Device problems

  • Break2

Patient problems

  • Device Embedded In Tissue or Plaque2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 22, 2017Break; Break

    IT WAS REPORTED THAT THE PATIENT HAD FUSION WITH IMPLANTS APPROXIMATELY ONE YEAR AGO WITH UNKNOWN SURGEON. PATIENT SUBSEQUENTLY FELL AT WORK AND WHEN AN XRAY WAS TAKEN, IT SHOWED THE SHAFTS OF BOTH S1 SCREWS BILATERALLY HAD SHEARED OFF FROM THE HEAD. POSTERIOR HARDWARE REMOVAL L5/S1 WAS PERFORMED. BECAUSE THERE WAS ALREADY BONY FUSION, ALL IMPLANTS WERE REMOVED WITHOUT REPLACEMENT.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 6811014 ↗
  • InjuryAug 22, 2017Break; Break

    IT WAS REPORTED THAT THE PATIENT HAD FUSION WITH IMPLANTS APPROXIMATELY ONE YEAR AGO WITH UNKNOWN SURGEON. PATIENT SUBSEQUENTLY FELL AT WORK AND WHEN AN XRAY WAS TAKEN, IT SHOWED THE SHAFTS OF BOTH S1 SCREWS BILATERALLY HAD SHEARED OFF FROM THE HEAD. POSTERIOR HARDWARE REMOVAL L5/S1 WAS PERFORMED. BECAUSE THERE WAS ALREADY BONY FUSION, ALL IMPLANTS WERE REMOVED WITHOUT REPLACEMENT.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 6810949 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041119, 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

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page