SIGMOID NOTCH 390-0315

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-06-17 for SIGMOID NOTCH 390-0315 manufactured by Small Bone Innovations, Inc..

Event Text Entries

[20792107] Disassociated sigmoid notch implant was explanted from a patient during a surgical procedure due to infection.
Patient Sequence No: 1, Text Type: D, B5

[20835216] Review of manufacturing records showed no anomalies.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3003640913-2011-00014
• MDR Report Key: 2142302
• Report Source: 05,07
• Date Received: 2011-06-17
• Date of Report: 2011-06-17
• Date of Event: 2011-05-18
• Date Mfgr Received: 2011-05-18
• Device Manufacturer Date: 2007-01-01
• Date Added to Maude: 2011-06-30
• 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: JAMES O'CONNOR
• Manufacturer Street: 1380 S. PENNSYLVANIA AVE.
• Manufacturer City: MORRISVILLE PA 19067
• Manufacturer Country: US
• Manufacturer Postal: 19067
• Manufacturer Phone: 2153376354
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SIGMOID NOTCH
• Generic Name: ULNAR HEAD PROSTHESIS
• Product Code: KXE
• Date Received: 2011-06-17
• Model Number: 390-0315
• Lot Number: 38489004/12-02
• Device Expiration Date: 2012-02-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMALL BONE INNOVATIONS, INC.
• Manufacturer Address: MORRISVILLE PA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2011-06-17