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

Model Number 283913000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2017

Event Type  malfunction  

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.Not returned for evaluation.

Event Description

Contrast medium was missing, intraoperatively the cement application could not reflected via x-ray visual inspection.

Manufacturer Narrative

Visual examination of the returned device found the mixed cement was stuck in the delivery system.The x-rays images provided confirmed the reported condition of the contrast medium was missing and the cement application not reflected in images.Product issue assessment was opened to further investigate the confidence cement issue.The preliminary root cause for this issue was attributed to supplier error.The raw materials for the cement were not mixed properly during manufacturing, and subsequent testing of the material was missed.The allegation has previously been investigated as part of the capa and escalated to field action.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONFIDENCE
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 7021718
• MDR Text Key: 92492761
• Report Number: 1526439-2017-10980
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: (01)10705034209630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 283913000
• Device Catalogue Number: 283913000
• Device Lot Number: 153884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1526439-12-15-2017-001-R
• Patient Sequence Number: 1