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EXPEDIUM 186172680Recalls & reported problems

Depuy Spine, LLC · EXPEDIUM SPINE SYSTEM EXTENDED TANDEM CONNECTOR 4.5 - 4.5 x 80mm · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034109145), received between Mar 19, 2022 and Mar 19, 2022 — classified as 1 malfunction.

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

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Material Twisted/Bent1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 19, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WAS PERFORMING A LENGTHENING ON A PATIENT AND THE TWO EXTENDED CONNECTORS IMPLANTED. THE EXPEDIUM 4.5 SET SCREW FROM THE CONNECTOR STRIPPED AND BROKE INSIDE THE CONNECTOR. THERE WAS A TWENTY MINUTE SURGICAL DELAY. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 13828073 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.