PROTEGRA *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-11 for PROTEGRA * manufactured by Mavig Gmbh.

Event Text Entries

[21709422] There have been three recent incidents of cracks occurring in the articulating arms manufactured by mavig used to support power injectors and lead shields. Two of these cracks have resulted in the arm to shear off completely and fall to the ground. The other arm did not fall; although a significant crack in the arm casing has been noted. All mavig arms have since been evaluated and those with defects or cracks have been removed from service entirely.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 851066
• MDR Report Key: 851066
• Date Received: 2007-05-11
• Date of Report: 2007-05-11
• Date of Event: 2007-04-10
• Report Date: 2007-05-11
• Date Reported to FDA: 2007-05-11
• Date Added to Maude: 2007-05-17
• 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: 0
• Reporter Occupation: RISK MANAGER
• 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: PROTEGRA
• Generic Name: ARM, ARTICULATING, EQUIPMENT SUPPORT
• Product Code: KPY
• Date Received: 2007-05-11
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 6 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 837813
• Manufacturer: MAVIG GMBH
• Manufacturer Address: CARE OF: TI-BA ENTERPRISES, IN 25 HYTEC CIRCLE ROCHESTER NY 14606 US

Device Sequence Number: 2

• Brand Name: PROTEGRA
• Generic Name: ARM, ARTICULATING, EQUIPMENT SUPPORT
• Product Code: KPY
• Date Received: 2007-05-11
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 5 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 837814
• Manufacturer: MAVIG GMBH
• Manufacturer Address: CARE OF: TI-BA ENTERPRISES, IN 25 HYTEC CIRCLE ROCHESTER NY 14606 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-05-11