MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE; CONFIDENCE CEMENT, BONE, VERTEBROPLASTY

Catalog Number 183901001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 08/18/2017

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

The patient had a traumatic accident.He hit a deer while riding a motorcycle.He sustained a t8-t9 fracture (hyperextension), a c6-t1 fracture, and had some renal injury.The patient also has coronary heart disease and had coronary bypass graft surgery at an unknown point in time.The surgeon proceeded on (b)(6) 2017 to surgically treat the t8-9 fracture.The patient has poor bone quality.During the surgery, he placed viper fenestrated screws at t7, t8, t10, and t11 via an open procedure.After the screws were placed, the surgeon used the depuy synthes fenestrated screw system to augment the vertebral bodies at the levels of the fenestrated screws.The surgeon injected approximately 2.5 cc of cement per screw and used 2 units of 11 cc confidence kits to augment the t7, t8, t10, and t11 screws.About mid way through injecting the confidence cement the anesthesiologist told the surgeon that the patient was getting hypotensive.He completed the injection of the last couple of screws.At that point the surgical team decided that it was best to perform a quick closure and not complete the procedure as the patient was not improving.They performed the quick closure.According to the nursing staff that patient was doing okay after he left the surgical room.It is unknown at this point what exactly happened.This is all the information that is available at this time.

• Brand Name: CONFIDENCE
• Type of Device: CONFIDENCE CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6870108
• MDR Text Key: 86436710
• Report Number: 1526439-2017-10738
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 183901001
• Device Lot Number: 8432626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR