MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE SPINAL CMT SYS, 11C; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 283910000

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

Patient Problem Sudden Cardiac Death (2510)

Event Date 12/01/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).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

It was reported surgeon performed revision surgery on (b)(6) 2017 to remove previous construct.Surgeon implanted patient with viper fenestrated screws and confidence cement.Procedure went well and surgeon closed the patient.Sales rep was notified by surgeon on (b)(6) 2017 that patient expired 3 hours post-op due to cement pulmonary embolism.

• Brand Name: CONFIDENCE SPINAL CMT SYS, 11C
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; CH
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7122207
• MDR Text Key: 94997297
• Report Number: 1526439-2017-50092
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209623
• UDI-Public: 10705034209623
• Combination Product (y/n): N
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 283910000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR