MCK TIBIAL BASEPLATE-RM/LL-SZ 6 180616

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2019-08-29 for MCK TIBIAL BASEPLATE-RM/LL-SZ 6 180616 manufactured by Mako Surgical Corp..

MAUDE Entry Details

• Report Number: 3005985723-2019-00626
• MDR Report Key: 8947010
• Report Source: HEALTH PROFESSIONAL,OTHER
• Date Received: 2019-08-29
• Date of Report: 2019-11-07
• Date of Event: 2019-08-06
• Date Mfgr Received: 2019-10-11
• Date Added to Maude: 2019-08-29
• 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: MAKO SURGICAL CORP.
• Manufacturer Street: 2555 DAVIE ROAD
• Manufacturer City: FORT LAUDERDALE FL 33317
• Manufacturer Country: US
• Manufacturer Postal Code: 33317
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MCK TIBIAL BASEPLATE-RM/LL-SZ 6
• Generic Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Product Code: NPJ
• Date Received: 2019-08-29
• Catalog Number: 180616
• Lot Number: 26151116-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• 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. Hospitalization; 2. Required No Informationntervention	2019-08-29