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BENGAL 177306122Recalls & reported problems

Medos International Sàrl · BENGAL STACKABLE CAGE SYSTEM STANDARD LORDOTIC 12 x 14 x 22mm, 0 DEGREES/6 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 10705034060835), received between May 6, 2017 and May 6, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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

  • Off-Label Use1

Patient problems

  • Injury1

Recent adverse event reports

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

  • InjuryMay 6, 2017Off-Label Use

    PATIENT UNDERWENT ANTERIOR CERVICAL CORPECTOMY AND FUSION (ACCF) AT (B)(6) ON (B)(6) 2014. THE ACCF WAS PERFORMED BY CLINICAL INVESTIGATORS DRS. (B)(6) UTILIZING THE BENGAL STACKABLE LORDOTIC CAGE (DEPUY-SYNTHES) IN STANDARD 12 X 14 FOOTPRINT AND 22MM HEIGHT. THE BENGAL STACKABLE CAGE WAS FILLED WITH GRAFTON (MEDTRONIC) AND LOCALLY HARVESTED AUTOGRAFT. A DURAL TEAR OCCURED REQUIRING REPAIR. REVIEW OF THE BENGAL STACKABLE 510(K) SUMMARY SHOWS THAT THE DEVICE WAS NOT APPROVED OR CLEARED FOR ANY INTENDED USE IN THE CERVICAL SPINE OF THE NECK AND EXPLICITLY CLEARED FOR USE IN LEVELS BELOW THE CERVICAL SPINE, YET THE CAGE DIMENSIONS AND LORDOTIC PROFILE ARE ONLY SUITABLE FOR USE IN THE CERVICAL SPINE. ACCORDING TO THE SPONSOR'S WEBSITE, "THE BENGAL STACKABLE CAGE SYSTEM IS INDICATED FOR USE IN THE CERVICAL OR THORACOLUMBAR SPINE (I.E., C2 TO L5) TO REPLACE A DISEASED VERTEBRAL BODY RESECTED OR EXCISED FOR THE TREATMENT OF TUMORS." [HTTPS://EMEA.DEPUYSYNTHES.COM/BINARY/ORG/DPY_SYN_EMEA/IFU_DOCUMENTS/EIFU-OVERVIEW/ELFU-0902-90-311REVA.PDF]. FDA HAS NOT APPROVED OR CLEARED USE OF THE DEVICE IN THE CERVICAL SPINE AND THEREFORE THE LABELING IS MISLEADING, FALSE AND OMITS MATERIAL SAFETY INFO

    Patient problems: Injury

    MAUDE report 6553828 ↗

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