MAUDE Adverse Event Report: SYNTHES GMBH INFLATION SYSTEM

Catalog Number 03.804.413S

Device Problems Filling Problem (1233); Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported on (b)(6); that during the preparation for unknown surgery on unknown date the vertebral body stenting inflation syst has leaked contrast medium during the filling.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Investigation could not be completed and no conclusion could be drawn as no device was returned.A review of device history records was performed and no complaint related issues were found during manufacturing that would contribute to this complaint.Placeholder.

• Brand Name: INFLATION SYSTEM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: gabriel szasz ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3582931
• MDR Text Key: 4136782
• Report Number: 8030965-2014-00122
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Catalogue Number: 03.804.413S
• Device Lot Number: 3011492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1