1.7MM CABLE WITH CRIMP 750MM-STERILE 298.801.01S

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 2019-11-21 for 1.7MM CABLE WITH CRIMP 750MM-STERILE 298.801.01S manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

• Report Number: 2939274-2019-62321
• MDR Report Key: 9353248
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2019-11-21
• Date of Report: 2019-10-22
• Date Mfgr Received: 2019-10-22
• Date Added to Maude: 2019-11-21
• 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: OTHER HEALTH CARE PROFESSIONAL
• 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: MONUMENT
• Manufacturer Street: 1101 SYNTHES AVENUE
• Manufacturer City: MONUMENT CO 80132
• Manufacturer Country: US
• Manufacturer Postal Code: 80132
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 1.7MM CABLE WITH CRIMP 750MM-STERILE
• Generic Name: CERCLAGE FIXATION
• Product Code: JDQ
• Date Received: 2019-11-21
• Model Number: 298.801.01S
• Catalog Number: 298.801.01S
• Lot Number: P318016
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• 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	1. Required No Informationntervention	2019-11-21