• 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 SPINE BENGAL STACK STD PAR 20MM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

  • 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 SPINE BENGAL STACK STD PAR 20MM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBENGAL STACK STD PAR 20MM
Type of DeviceSPINAL 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 Key4204111
MDR Text Key4964179
Report Number1526439-2014-12032
Device Sequence Number1
Product Code MQP
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberPK073649
Number of Events Reported1
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 Received10/27/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device Catalogue Number177300120
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Hospital
Date Manufacturer Received10/01/2014
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
-
-