MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM 180734-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-30 for MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM 180734-1 manufactured by Mako Surgical Corp..

MAUDE Entry Details

• Report Number: 3005985723-2019-00762
• MDR Report Key: 9255052
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2019-10-30
• Date of Report: 2019-10-30
• Date of Event: 2019-10-02
• Date Mfgr Received: 2019-10-02
• Device Manufacturer Date: 2019-01-09
• Date Added to Maude: 2019-10-30
• 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: MR. COLLIN NEITZEL
• Manufacturer Street: 325 CORPORATE DRIVE
• Manufacturer City: MAHWAH NJ 07430
• Manufacturer Country: US
• Manufacturer Postal: 07430
• Manufacturer Phone: 2018315000
• Manufacturer G1: STRYKER ORTHOPAEDICS-MAHWAH
• Manufacturer Street: 325 CORPORATE DRIVE
• Manufacturer City: MAHWAH NJ 07430
• Manufacturer Country: US
• Manufacturer Postal Code: 07430
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM
• Generic Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Product Code: NPJ
• Date Received: 2019-10-30
• Catalog Number: 180734-1
• Lot Number: 5K8L5K
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MAKO SURGICAL CORP.
• Manufacturer Address: 2555 DAVIE ROAD FORT LAUDERDALE FL 33317 US 33317

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-10-30