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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-19 for * manufactured by Stryker.

Event Text Entries

[15116011] During bone marrow aspirate concentrate (bmac) procedure on left side a drill guide broke. A piece of it was retained in the greater trochanter and femoral head. Doctor made the decision to leave the drill guide in the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4506888
• MDR Report Key: 4506888
• Date Received: 2014-12-19
• Date of Report: 2014-12-19
• Date of Event: 2014-12-02
• Report Date: 2014-12-19
• Date Reported to FDA: 2014-12-19
• Date Reported to Mfgr: 2015-02-11
• Date Added to Maude: 2015-02-11
• 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 Details

• Brand Name: *
• Generic Name: GUIDE, DRILL
• Product Code: LXI
• Date Received: 2014-12-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER
• Manufacturer Address: 4100 EAST MILHAM AVE. KALAMAZOO, MI 49001 US 49001

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-12-19