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CONCORDE 187827409Recalls & reported problems

Medos International Sàrl · CONCORDE BULLET SPINAL SYSTEM LORDOTIC IMPLANT 9 x 9 x 27mm, 5 DEGREES · Class 2 · Implant

All models of CONCORDE (24)

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

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 10705034140063), received between Apr 10, 2018 and May 27, 2020 — 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. 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

  • No Consequences Or Impact To Patient2
  • No Code Available1

Recent adverse event reports

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

  • MalfunctionMay 27, 2020Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS INSERTING A 9X50MM SCREW AND THE SCREWDRIVER TIP BROKE INSIDE THE SCREW, THE SCREW WAS REMOVED SUCCESSFULLY. SURGEON WAS INSERTING 9X27MM CAGE AND THE CAGE CRACKED, CAGE REMOVED SUCCESSFULLY. SURGEON WAS TRYING TO ADJUST AN 8X50MM SCREW AND THE DRIVER TIP BROKE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 30-MINUTE SURGICAL DELAY, PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: EXP TI POLY SCREW 8MMX50MM (PART# 179712850, LOT# UNKNOWN , QUANTITY 1) EXP TI POLY SCREW 9MMX50MM (PART# 179712950, LOT# UNKNOWN , QUANTITY 1) THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Patient problems: No Code Available; No Consequences Or Impact To Patient

    MAUDE report 10092590 ↗
  • MalfunctionApr 10, 2018Break; Break

    IT WAS REPORTED THE SURGEON WAS TRYING TO PLACE A CAGE AT L5-S1 DISC SPACE. HE WAS COMING IN LATERALLY THEN PULLED HIS HAND DOWN WITH INSERTER TO DRIVE THE CAGE TO A MORE MIDLINE APPROACH AND THE CAGE BROKE OFF AT THE INSTRUMENT/CAGE INTERFACE. THIS HAPPENED WITH BOTH CAGES. THEN PROCEEDED TO USE THE DUAL PREP INSTRUMENT TO GET MORE MIDLINE AND THEN THE THIRD CAGE WAS PLACED TO HIS SATISFACTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7411583 ↗

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Sources and updates

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