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CONCORDE 292954602Recalls & reported problems

Depuy Spine, LLC · CONCORDE LS LATERAL INTERBODY INSTRUMENT SYSTEM UP ANGLE PITUITARY 6mm · Class 1

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 10705034226347), received between Jun 25, 2021 and Jun 25, 2021 — 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

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.

  • MalfunctionJun 25, 2021Break; Break

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF THIS INSTRUMENT BROKE AS THE SURGEON WAS TRYING TO GRAB AND REMOVE A PIECE OF BONE. VARIOUS PLIERS, WRENCHES AND CUTTING DISCS WERE USED TO GRAB ONTO THE SCREW AND TRY TO UNSCREW IT. THE PROCEDURE TOOK 20-30 MIN TO REMOVE THE SCREW. ITEM 2929-54-602: THE TIP OF THIS INSTRUMENT BROKE AS THE SURGEON WAS TRYING TO GRAB AND REMOVE A PIECE OF BONE. ITEMS 2997-04-152 [X 2]: THIS ONE PART OF A 3-PART SCREW DRIVER ASSEMBLY. FOR SOME REASON, THE SCREWDRIVER WOULD DISASSEMBLE BY ITSELF WHEN A SCREW WAS LOADED AND TIGHTENED. I TRIED DIFFERENT PARTS FROM ANOTHER SET AND IT WAS DETERMINED THAT THESE WERE THE DEFECTIVE PARTS. ITEM 279712400: THE TIP OF THIS SCREWDRIVER BROKE AND GOT STUCK INSIDE THE SCREW HEAD. IT WAS A LARGE SCREW AND THE BONE WAS VERY HARD. THE SCREW WAS PARTIALLY IN THE BONE WHEN THE DRIVER BROKE. THE SCREW WAS EVENTUALLY REMOVED USING VARIOUS METHODS AND TOOLS. SURGERY GOT DELAYED BY AT LEAST 20-30 MIN. NO IMPACT ON PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN SHAFT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKN

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12071147 ↗

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