MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI DISTAL EXTENSION; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.119

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that examination after an abrupt fall, revealed a broken vertical expandable prosthetic titanium rib ii distal extension adjacent to the most cranial screw in a rib to spine construct.The initial implant date was in (b)(6) 2005.The distal extension was removed and replaced; uss dual opening screws were also replaced at the same time.Surgery was successfully completed.This is 1 of 1 report for (b)(4).This report is for the titanium distal extension.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Pt identifier: patient case id# (b)(6).Implant date: (b)(6) 2005.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history record revealed no complaint related anomalies.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI DISTAL EXTENSION
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3679614
• MDR Text Key: 4255190
• Report Number: 2530088-2014-10034
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.119
• Device Lot Number: 6269387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 20