Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY-SYNTHES BENGAL STACKABLE CAGE SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY-SYNTHES BENGAL STACKABLE CAGE SYSTEM Back to Search Results
Model Number 1773-06-130
Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)
Patient Problem Pain (1994)
Event Date 06/10/2013
Event Type  Injury  
Event Description
In (b)(6) 2013, dr (b)(6) performed anterior cervical corpectomy using the bengal monolith stackable cage.The carbon-fiber corpectomy cage is not fda approved or cleared by the fda for use in the neck.The device is in design construct consists of a footprint of 12x14mm and height of 30mm and was explicitly cleared for use in back (t1-l5), not in the neck.The labeling does not disclose any safety/risk profile for use in the cervical spine.My symptoms initially improved but have been experiencing worsening pain in my hands, shoulders.Post-operative imaging studies appear to show the device positioned upside-down from its normal orientation and also with clinically significant subsident or "pistoning" into the adjacent vertebra.The surgeon also did not disclose financial ties to the device manufacturer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BENGAL STACKABLE CAGE SYSTEM
Type of Device
BENGAL STACKABLE CAGE SYSTEM
Manufacturer (Section D)
DEPUY-SYNTHES
MDR Report Key6456398
MDR Text Key71748067
Report NumberMW5068871
Device Sequence Number1
Product Code MQP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1773-06-130
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/02/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
OTC MEDS: NA; RX MEDS: NA
Patient Outcome(s) Other; Disability;
Patient Age42 YR
Patient Weight93
-
-