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BENGAL 177306132Recalls & reported problems

Depuy Spine, LLC · BENGAL STACKABLE CAGE SYSTEM STANDARD LORDOTIC 12 x 14 x 32mm, 0 DEGREES/6 DEGREES · 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 10705034060880), received between Dec 18, 2019 and Dec 18, 2019 — 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 Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionDec 18, 2019Break; Break

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE CAGE CONTAINED WHAT LOOKED LIKE FLAKING CARBON FIBER WITHIN THE IMPLANT. THERE WAS A LARGE AMOUNT OF DEBRIS THAT CAME OUT FROM INSIDE THE CAGE. THIS REPORT IS FOR A BENGAL STACK CAGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9491909 ↗

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