ANALOG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-10 for ANALOG manufactured by Biomet 3i.

Event Text Entries

[178560450] Zimmerbiomet complaint number (b)(4).
Patient Sequence No: 1, Text Type: N, H10

[178560451] It was reported that the analog was unable to disengage from the implant. The implant was removed. Tooth location 19.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001038806-2020-00308
• MDR Report Key: 9689781
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-02-10
• Date of Report: 2020-02-10
• Date of Event: 2019-11-15
• Date Mfgr Received: 2020-01-17
• Date Added to Maude: 2020-02-10
• 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: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS SUSANNE TAYLOR
• Manufacturer Street: 4555 RIVERSIDE DRIVE
• Manufacturer City: PALM BEACH GARDENS FL 33410
• Manufacturer Country: US
• Manufacturer Postal: 33410
• Manufacturer Phone: 5617766700
• Manufacturer G1: BIOMET 3I
• Manufacturer Street: 4555 RIVERSIDE DRIVE
• Manufacturer City: PALM BEACH GARDENS FL 33410
• Manufacturer Country: US
• Manufacturer Postal Code: 33410
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: ANALOG
• Product Code: NDP
• Date Received: 2020-02-10
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOMET 3I
• Manufacturer Address: 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-02-10