MAUDE Adverse Event Report: DEPUY SYNTHES SPINE BENGAL STACK STD PAR 20MM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 177300120

Device Problem Positioning Problem (3009)

Patient Problems Quadriplegia (2449); Blood Loss (2597)

Event Date 09/30/2014

Event Type  Injury  

Event Description

Spine revision was performed on (b)(6) 2014 by dr (b)(6). Revision was performed due to subsidence of the bengal cage. Also, it was reported that a concomitant device skyline plate and four concomitant device skyline variable screws had moved due to patient's anatomy and were removed and replaced during the revision. However, these variable screws are intended to move/toggle to allow loading of the graft. If the graft subsides the screws will not and are not intended to provide further resistance to motion. The screws and the plate did not cause or contribute to the event. Implantation date is not known. The devices were discarded. Patient outcome: patient appears to have irreversible c7 quadriplegia. Post-operative mri was performed and rep was informed that the quadriplegia was due to query devascularisation.

Manufacturer Narrative

Concomitant products: depuy synthes spine does not use therapy dates as required as the implant date is unknown, the date of this report has been entered into the required field. A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Discarded by customer.

• Brand Name: BENGAL STACK STD PAR 20MM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 4204111
• MDR Text Key: 4964179
• Report Number: 1526439-2014-12032
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (Y/N): N
• Reporter Country Code: AS
• PMA/PMN Number: PK073649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/01/2014

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/27/2014
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No

Device Operator

• Device Catalogue Number: 177300120
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/01/2014
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 10/27/2014 Patient Sequence Number: 1

Treatment

SKYLINE PLATE, 186801026; SKYLINE VAR. SCREWS, 186850014 X 4