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BENGAL 177300310Recalls & reported problems

Depuy Spine, LLC · BENGAL STACKABLE CAGE SYSTEM CAGE MIDDLE, LARGE 14 x 16 x 10mm, 0 DEGREES · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034060521), received between Jun 28, 2017 and Jun 28, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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

  • Migration or Expulsion of Device1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • InjuryJun 28, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

    PROCEDURE: CERVICAL CORPECTOMY. THE PATIENT WAS PREVIOUSLY OPERATED ON (B)(6) 2017 FOR A 3/4 CERVICAL FUSION, 4/5 CERVICAL DISC ARTHROPLASTY AND C5-7 CERVICAL FUSION. ON THE DAY THE C5-7 FUSION RESULTED IN A CORPECTOMY OF C6 AND A BENGAL STACKABLE CAGE AND SKYLINE PLATE WAS IMPLANTED. THE PATIENT HAS PRESENTED WITH CAGE SUBSIDENCE AT C5-7. THE SURGEON HAS INDICATED THAT THIS WAS NOT A RESULT OF IMPLANT FAILURE BUT DUE TO THE PATIENT POOR QUALITY BONE. SUBSEQUENTLY THE C5-7 SKYLINE PLATE AND CAGE HAS BEEN REMOVED, A CORPECTOMY OF C7 HAS BEEN PERFORMED AND A LONGER STACKABLE CAGE AND PLATE HAS BEEN IMPLANTED. UNFORTUNATELY THE NURSE HAD DISPOSED OF THE IMPLANTS SO THEY ARE NOT ABLE TO BE RETURNED, HOWEVER AS STATED EARLIER THE SURGEON HAS SAID THAT THE SUBSIDENCE WAS NOT DUE TO ANY IMPLANT FAILURE BUT DUE TO POOR BONE QUALITY.

    Patient problems: Failure of Implant

    MAUDE report 6674106 ↗

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