MAUDE Adverse Event Report: DEPUY-SYNTHES BENGAL STACKABLE MONOLITH

Model Number	177306122
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/21/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
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 information.No patient consent or disclosure that use of the device was not approved or cleared by fda for use in the cervical spine.No disclosure that use of the device in the cervical spine presents risks to anatomic structures unique to the neck.

• Brand Name: BENGAL STACKABLE MONOLITH
• Common Device Name: BENGAL STACKABLE MONOLITH
• Manufacturer (Section D): DEPUY-SYNTHES
• MDR Report Key: 6553828
• Report Number: MW5069632
• Device Sequence Number: 788388
• Product Code: MQP
• UDI-Device Identifier: 10705034060835
• UDI-Public: 10705034060835
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Voluntary
• Initial Reporter Occupation: No Information
• Type of Report: Initial
• Report Date (Section B): 05/06/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 177306122
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OTC MEDS: NA; RX MEDS: NA
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 59