PSI SD800.534 PEEK IMPLANT

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 2019-10-11 for PSI SD800.534 PEEK IMPLANT manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

• Report Number: 2939274-2019-61441
• MDR Report Key: 9180208
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-10-11
• Date of Report: 2019-09-25
• Date Mfgr Received: 2019-11-04
• Date Added to Maude: 2019-10-11
• 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: 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: PSI SD800.534 PEEK IMPLANT
• Generic Name: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Product Code: GXN
• Date Received: 2019-10-11
• Returned To Mfg: 2019-10-30
• Model Number: SD800.534
• Catalog Number: SD800.534
• Lot Number: 12L4452
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• 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	2019-10-11