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CONCORDE 287903003Recalls & reported problems

Depuy Spine, LLC · CONCORDE SYSTEM RASP, RIGHT ANGLE · Class 1

All models of CONCORDE (9)

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

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 10705034219943), received between May 5, 2023 and May 5, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMay 5, 2023Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE ANGLED RASP HANDLE WAS BROKEN, THE BLADE HOLDER MECHANISM WAS STUCK, AND THE PROBE THREADS WERE WORN OUT, AND THE X25 INSERTER TIP WAS BENT. THERE WAS NO EXTENSION OF SURGERY TIME AND NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED WITH SIMILAR PRODUCTS. THIS REPORT INVOLVES ONE CONCORDE SYSTEM RASP, RIGHT ANGLE. THIS REPORT IS RELATED TO (B)(4). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16875349 ↗

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Sources and updates

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