FIBULA SHAFT * 850600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-16 for FIBULA SHAFT * 850600 manufactured by Musculoskeletal Transplant Foundation.

Event Text Entries

[450940] Patient developed post-open reduction with internal fixation (clavicle) infection, as well as hardware loosening.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 694582
• MDR Report Key: 694582
• Date Received: 2006-02-16
• Date of Report: 2006-02-15
• Date of Event: 2006-01-10
• Report Date: 2006-02-15
• Date Reported to FDA: 2006-02-16
• Date Added to Maude: 2006-04-04
• 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: FIBULA SHAFT
• Generic Name: BONE SHAFT, TISSUE
• Product Code: LMO
• Date Received: 2006-02-16
• Model Number: *
• Catalog Number: 850600
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 1 DY
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 683709
• Manufacturer: MUSCULOSKELETAL TRANSPLANT FOUNDATION
• Manufacturer Address: 125 MAY STREET EDISON NJ 08837 US

Device Sequence Number: 2

• Brand Name: DBX PUTTY , 5CC
• Generic Name: DEMINERALIZED BONE
• Product Code: MQV
• Date Received: 2006-02-16
• Model Number: *
• Catalog Number: 038050
• Lot Number: *
• ID Number: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 683710
• Manufacturer: MUSCULOSKELETAL TRANSPLANT FOUNDATION
• Manufacturer Address: 125 MAY STREET EDISON NJ 08837 US
• Baseline Brand Name: DBX DEMINERALIZED BONE MATRIX, 5 CC
• Baseline Generic Name: BONE VOID FILLER
• Baseline Model No: *
• Baseline Catalog No: 038050
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2006-02-16