MIS TI CFX FEN POLY 6X45 186727645

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-25 for MIS TI CFX FEN POLY 6X45 186727645 manufactured by Medos International Sàrl Ch.

MAUDE Entry Details

• Report Number: 1526439-2019-52489
• MDR Report Key: 9371418
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-11-25
• Date of Report: 2019-10-30
• Date Mfgr Received: 2019-10-30
• Date Added to Maude: 2019-11-25
• 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: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: KARA DITTY-BOVARD
• Manufacturer Street: 325 PARAMOUNT DRIVE
• Manufacturer City: RAYNHAM MA 02767
• Manufacturer Country: US
• Manufacturer Postal: 02767
• Manufacturer Phone: 6103142063
• Manufacturer G1: BRIDGEWATER DISTRIBUTION
• Manufacturer Street: 50 SCOTLAND BOULEVARD
• Manufacturer City: BRIDGEWATER MA 02324
• Manufacturer Country: US
• Manufacturer Postal Code: 02324
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MIS TI CFX FEN POLY 6X45
• Generic Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Product Code: PML
• Date Received: 2019-11-25
• Returned To Mfg: 2019-11-18
• Model Number: 186727645
• Catalog Number: 186727645
• Lot Number: 255869
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDOS INTERNATIONAL SàRL CH
• Manufacturer Address: CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-11-25