MAUDE Adverse Event Report: DEPUY-SYNTHES BENGAL STACKABLE; SPINAL FIXATION DEVICE

Model Number 177306124

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 08/22/2016

Event Type  Injury  

Event Description

I had a failed cervical corpectomy procedure involving a corpectomy spinal cage that is not fda approved or cleared for use in the neck.Medical records show the device to be the 24mm tall x 12x14mm footprint standard lordotic bengal stackable monolith.A depuy-synthes sales rep was also present during the failed operative procedure.Within one week, i was informed the procedure failed, but was never told the failure was related to device subsidence and/or migration.I had to undergo posterior cervical fusion.I was never informed by my surgeon, hospital representative or device representative that the spinal corpectomy cage was not fda approved or cleared for use in the cervical spine.Despite the curative posterior fusion surgery, my left arm and hand are wasting away.The instructions for use and materials on the depuy-synthes website advertise the bengal stackable/monolith as a spinal cage that doctors are supposed to implant the device in the back below levels of the cervical spine, but this is impossible since the spinal cage is too small and configured to fit the curvature of the neck.The device labeling is completely inadequate and provides misleading information about what the device is designed to actually do and where it is actually supposed to be implanted.Though imaging studies show that the device was used to fill the void at the c6 vertebral body and c5-6 and c6-7 adjacent disc spaces, the procedure was billed as a three-level partial cervical corpectomy.I have reported these findings to the insurance benefits companies as the billing cpt codes are not consistent with the actual procedure performed or the imaging studies.My consent form also never disclosed that use of the device was not fda approved in the neck or any of the complications or risks of using the device or in the event of device-related failures in the neck.

• Brand Name: BENGAL STACKABLE
• Type of Device: SPINAL FIXATION DEVICE
• Manufacturer (Section D): DEPUY-SYNTHES
• MDR Report Key: 6364007
• MDR Text Key: 68753566
• Report Number: MW5068169
• Device Sequence Number: 1
• Product Code: MQP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/26/2017

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
• Device Operator: Health Professional
• Device Model Number: 177306124
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: GABAPENTIN. ; OTC MEDS: NA. ; RX MEDS: TRAMADOL
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Weight: 68