ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS 388.50

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-23 for ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS 388.50 manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

• Report Number: 2939274-2019-61722
• MDR Report Key: 9227004
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-10-23
• Date of Report: 2019-10-04
• Date Mfgr Received: 2019-11-27
• Device Manufacturer Date: 2016-10-26
• 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: KARA DITTY-BOVARD
• Manufacturer Street: 1302 WRIGHTS LANE EAST
• Manufacturer City: WEST CHESTER PA 19380
• Manufacturer Country: US
• Manufacturer Postal: 19380
• Manufacturer Phone: 6103142063
• Manufacturer G1: SYNTHES TUTTLINGEN
• Manufacturer Street: UNTER HASSLEN 5
• Manufacturer City: TUTTLINGEN 78532
• Manufacturer Country: GM
• Manufacturer Postal Code: 78532
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS
• Generic Name: PLIERS,SURGICAL
• Product Code: HTC
• Date Received: 2019-10-23
• Returned To Mfg: 2019-10-11
• Model Number: 388.50
• Catalog Number: 388.50
• Lot Number: T134820
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: WRIGHTS LANE SYNTHES USA PRODUCTS LLC
• Manufacturer Address: 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-10-23