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CONCORDE 287902000Recalls & reported problems

Depuy Spine, LLC · CONCORDE SYSTEM STRAIGHT IMPACTOR · Class 1

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034219905), received between Nov 15, 2021 and Apr 18, 2023 — classified as 2 malfunctions.

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

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

  • Break2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionApr 18, 2023Break; Break

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A TLIF (L4/5) FOR LSCS ON (B)(6) 2023. A CAGE WAS INSERTED USING AN INSERTER. THE HANDLE OF THE MPACTOR BROKE WHEN THE IMPACTOR USED AT THE FINAL STAGE OF INSERTION. THE BREAKAGE OCCURRED OUT OF THE SURGICAL FIELD, AND BROKEN FRAGMENTS SEEMED NOT TO BE IN THE PATIENT¿S BODY, BUT THE SURGEON WASHED THE AFFECTED SITE JUST TO BE SURE. THE SURGEON CONFIRMED THAT THERE WAS NOTHING LEFT IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) CONCORDE IMPCTR STRGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16765236 ↗
  • MalfunctionNov 15, 2021Break; Break

    LIBERTAS: IT WAS REPORTED THAT ON (B)(6) 2021, THE CONCORDE IMPACTOR STRAIGHT WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT THIRD PARTY SERVICER. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CONCORDE IMPACTOR STRAIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12814985 ↗

Other IMPACTOR devices

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