MEDTRONIC ATLANTIS PLATING *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-03 for MEDTRONIC ATLANTIS PLATING * manufactured by Medtronic Sofamor Danek, Global Quality.

Event Text Entries

[18239964] Due to severe lower extremity weakness and bilateral upper extremity radicular pain/weakness, the pt underwent c4, c5, c6 corpectomies and c3 and c7 fusion in 2006. The pt did well post-operatively. Eleven days later, pt was readmitted and taken emergently to the or due to increased weakness and pain and cervical ct findings. Pt underwent a re-do of c3-c7 cervical plate and interbody graft, c7 corpectomy and spinal cord decompression, c3 to t1 anterior cervical fusion with grafting/plating. Post procedure pt moving upper and lower extremities upon awakening and was transported to the icu in stable condition.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 782720
• MDR Report Key: 782720
• Date Received: 2006-11-03
• Date of Report: 2006-10-12
• Date of Event: 2006-09-30
• Date Facility Aware: 2006-10-02
• Report Date: 2006-10-12
• Date Reported to Mfgr: 2006-10-12
• Date Added to Maude: 2006-11-21
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: MEDTRONIC ATLANTIS PLATING
• Generic Name: DUREPAIR 2.5CM X 2.5CM
• Product Code: GXQ
• Date Received: 2006-11-03
• Model Number: *
• Catalog Number: *
• Lot Number: 0603012
• ID Number: 62111
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 11 DAY
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 770518
• Manufacturer: MEDTRONIC SOFAMOR DANEK, GLOBAL QUALITY
• Manufacturer Address: 1800 PYRAMID PLACE MEMPHIS TN 38132 US
• Baseline Brand Name: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
• Baseline Generic Name: BONE SCREW
• Baseline Model No: *
• Baseline Catalog No: UNK
• Baseline ID: 62111

Device Sequence Number: 2

• Brand Name: MEDTRONIC ATLANTIS PLATING
• Generic Name: CORNERSTONE PSR 14 X 11 X 10MM
• Product Code: LYQ
• Date Received: 2006-11-03
• Model Number: *
• Catalog Number: 976.167
• Lot Number: LP70
• ID Number: 67.5MM, 6277041
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 11 DAY
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 770531
• Manufacturer: MEDTRONIC SOFAMOR DANEK, GLOBAL QUALITY
• Manufacturer Address: 1800 PYRAMID PLACE MEMPHIS TN 38132 US
• Baseline Brand Name: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
• Baseline Generic Name: ANTERIOR CERVICAL PLATE
• Baseline Model No: NA
• Baseline Catalog No: 976-167
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2006-11-03