128040

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 2009-05-11 for 128040 manufactured by Brooks Manufacturing Site.

Event Text Entries

[1201949] It was reported that the k-wire bent approximately 6 weeks after the initial surgery, and that a revision surgery was required to correct.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1020279-2009-00562
• MDR Report Key: 1379344
• Report Source: 07
• Date Received: 2009-05-11
• Date of Report: 2009-05-08
• Date of Event: 2009-05-05
• Date Mfgr Received: 2009-05-08
• Device Manufacturer Date: 2008-04-01
• Date Added to Maude: 2009-05-14
• 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: MR. JERRY HOWARD
• Manufacturer Street: 1450 BROOKS RD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal: 38116
• Manufacturer Phone: 9013996153
• Manufacturer G1: BROOKS MANUFACTURING SITE
• Manufacturer Street: 1450 BROOKS ROAD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal Code: 38116
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: K-WIRE / DZK
• Product Code: DZK
• Date Received: 2009-05-11
• Catalog Number: 128040
• Lot Number: 08DM10187
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BROOKS MANUFACTURING SITE
• Manufacturer Address: MEMPHIS TN US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2009-05-11