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

Catalog Number UNK-CEMENT/CEM ACCESORY

Device Problem Filling Problem (1233)

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

Event Date 06/17/2017

Event Type  malfunction  

Manufacturer Narrative

Unknown part number, udi is unavailable.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.Device not returned.

Event Description

According to feedback from dr.(b)(6), the confidence cement he used had no contrast medium.He has not seen the cement during the application with the hydraulic system.In addition, he said that the cement was too much liquid.Dr.(b)(6) will not use confidence anymore he will switch to vertecem v + in addition he thinks, that the mixing ratio between monomer and powder was wrong.

• Brand Name: CONFIDENCE SPINAL CEMENT SYSTEM
• Type of Device: 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: 6718524
• MDR Text Key: 80266565
• Report Number: 1526439-2017-10593
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: UNK-CEMENT/CEM ACCESORY
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1