POTTS ELEVATOR #2 LEFT N/A 09-0364

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-10-23 for POTTS ELEVATOR #2 LEFT N/A 09-0364 manufactured by Biomet Microfixation.

MAUDE Entry Details

• Report Number: 0001032347-2019-00467
• MDR Report Key: 9225273
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2019-10-23
• Date of Report: 2019-10-22
• Date of Event: 2019-09-19
• Date Mfgr Received: 2019-09-24
• Device Manufacturer Date: 2015-09-23
• Date Added to Maude: 2019-10-23
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. LAKESHIA SMOOT
• Manufacturer Street: 1520 TRADEPORT DRIVE
• Manufacturer City: JACKSONVILLE FL 32218
• Manufacturer Country: US
• Manufacturer Postal: 32218
• Manufacturer Phone: 9047414400
• Manufacturer G1: BIOMET MICROFIXATION
• Manufacturer Street: 1520 TRADEPORT DRIVE
• Manufacturer City: JACKSONVILLE FL 32218
• Manufacturer Country: US
• Manufacturer Postal Code: 32218
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: N/A
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: POTTS ELEVATOR #2 LEFT
• Generic Name: ELEVATOR, SURGICAL, DENTAL
• Product Code: EMJ
• Date Received: 2019-10-23
• Model Number: N/A
• Catalog Number: 09-0364
• Lot Number: 032615C15
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOMET MICROFIXATION
• Manufacturer Address: 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-10-23