IMPACTION BUR GUARD 2296-301-000 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1996-12-06 for IMPACTION BUR GUARD 2296-301-000 NA manufactured by Stryker Instruments.

Event Text Entries

[29106] Bur guard heated up and burned up.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1811755-1996-00260
• MDR Report Key: 54232
• Report Source: 00
• Date Received: 1996-12-06
• Date of Event: 1996-09-04
• Date Mfgr Received: 1996-11-08
• Date Added to Maude: 1996-12-10
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: IMPACTION BUR GUARD
• Generic Name: BUR GUARD
• Product Code: EEJ
• Date Received: 1996-12-06
• Model Number: 2296-301-000
• Catalog Number: NA
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 54802
• Manufacturer: STRYKER INSTRUMENTS
• Manufacturer Address: 4100 E MILHAM AVE KALAMAZOO MI 49001 US
• Baseline Brand Name: IMPACTION DRILL BUR GUARD
• Baseline Generic Name: GUARD, DISK
• Baseline Model No: 2296-301-000
• Baseline Catalog No: NA
• Baseline ID: NA
• Baseline Device Family: IMPACTION GUARD/SHIELDS
• Baseline Shelf Life Contained: A
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K953071
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1996-12-06