*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-24 for * manufactured by Kls Martin.

Event Text Entries

[18965822] Pt was involved in a motor vehicle accident in 09/02. Pt was taken to surgery for an open reduction and internal fixation of comminuted right and left fracture of the mandibular body. Pt was returned to the or for incision and drainage of left mandibular abscess and removal of broken mandibular fixation plates. Per the physician, the pt had soft bones that wouldn't break the plate, and he feels the problem was with the plate itself. Two kls reps were present for first surgery. Pt expired 16 days later after cardiac arrest.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 434953
• MDR Report Key: 434953
• Date Received: 2002-12-24
• Date of Report: 2002-12-20
• Date of Event: 2002-11-19
• Date Facility Aware: 2002-12-06
• Report Date: 2002-12-20
• Date Reported to FDA: 2002-12-23
• Date Reported to Mfgr: 2002-12-20
• Date Added to Maude: 2003-01-02
• 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
• 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: *
• Generic Name: MANDIBULAR PLATE - LEVEL ONE
• Product Code: NDF
• Date Received: 2002-12-24
• Model Number: *
• Catalog Number: *
• Lot Number: UNK
• ID Number: RIGHT-8 HOLE RIGID BLUE PLATE
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 423910
• Manufacturer: KLS MARTIN
• Manufacturer Address: PO BOX 50249 JACKSONVILLE FL 322500249 US

Device Sequence Number: 2

• Brand Name: *
• Generic Name: MANDIBULAR PLATE-LEVEL ONE
• Product Code: NDF
• Date Received: 2002-12-24
• Model Number: *
• Catalog Number: *
• Lot Number: UNK
• ID Number: LEFT-8 HOLE RIGID BLUE PLATE
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 423914
• Manufacturer: KLS MARTIN
• Manufacturer Address: PO BOX 50249 JACKSONVILLE FL 322500249 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2002-12-24