PERIOSTEAL ELEVATOR 14MM STRAIGHT BLADE-ROUND EDGE 399.37

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-15 for PERIOSTEAL ELEVATOR 14MM STRAIGHT BLADE-ROUND EDGE 399.37 manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

• Report Number: 2939274-2019-61545
• MDR Report Key: 9191798
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-10-15
• Date of Report: 2019-09-20
• Date of Event: 2019-09-18
• Date Mfgr Received: 2019-10-30
• Date Added to Maude: 2019-10-15
• 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: 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: PERIOSTEAL ELEVATOR 14MM STRAIGHT BLADE-ROUND EDGE
• Generic Name: ELEVATOR
• Product Code: HTE
• Date Received: 2019-10-15
• Returned To Mfg: 2019-10-23
• Model Number: 399.37
• Catalog Number: 399.37
• 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		2019-10-15