PLUS NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-05-14 for PLUS NI manufactured by Rotkreuz Switzerland Manufacturing Site.

Event Text Entries

[16520707] Na
Patient Sequence No: 1, Text Type: N, H10

[16641935] It has been reported that a revision surgery was performed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9612771-2009-00104
• MDR Report Key: 1385968
• Report Source: 07
• Date Received: 2009-05-14
• Date of Report: 2009-05-14
• Date of Event: 2008-04-15
• Date Mfgr Received: 2009-04-16
• Date Added to Maude: 2009-05-19
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: MRS. LEAH EASLEY
• Manufacturer Street: 1450 BROOKDS ROAD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal: 38116
• Manufacturer Phone: 9013996137
• Manufacturer G1: ROTKREUZ SWITZERLAND MANUFACTURING SITE
• Manufacturer Street: ERLENSTRASSE 4A
• Manufacturer City: ROTKREUZ 6343
• Manufacturer Country: SZ
• Manufacturer Postal Code: 6343
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PLUS
• Generic Name: SL PLUS STEM / KXD
• Product Code: KXD
• Date Received: 2009-05-14
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROTKREUZ SWITZERLAND MANUFACTURING SITE
• Manufacturer Address: ROTKREUZ

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2009-05-14