LEVO ARM HEAD POSITIONING SYSTEM REF 7887-050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-07 for LEVO ARM HEAD POSITIONING SYSTEM REF 7887-050 manufactured by Mizuho Osi (orthopedic Systems, Inc.).

MAUDE Entry Details

• Report Number: MW5090971
• MDR Report Key: 9295572
• Date Received: 2019-11-07
• Date of Report: 2019-11-06
• Date of Event: 2019-10-25
• Date Added to Maude: 2019-11-08
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: LEVO ARM HEAD POSITIONING SYSTEM
• Generic Name: SUPPORT, PATIENT POSITION
• Product Code: CCX
• Date Received: 2019-11-07
• Returned To Mfg: 2019-10-31
• Catalog Number: REF 7887-050
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MIZUHO OSI (ORTHOPEDIC SYSTEMS, INC.)
• Manufacturer Address: UNION CITY CA 94587 US 94587

Device Sequence Number: 2

• Brand Name: LEVO ARM HEAD POSITIONING SYSTEM
• Generic Name: SUPPORT, PATIENT POSITION
• Product Code: CCX
• Date Received: 2019-11-07
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MIZUHO OSI (ORTHOPEDIC SYSTEMS, INC.)
• Manufacturer Address: UNION CITY CA 94587 US 94587

Device Sequence Number: 3

• Brand Name: LEVO ARM HEAD POSITIONING SYSTEM
• Generic Name: SUPPORT, PATIENT POSITION
• Product Code: CCX
• Date Received: 2019-11-07
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: MIZUHO OSI (ORTHOPEDIC SYSTEMS, INC.)
• Manufacturer Address: UNION CITY CA 94587 US 94587

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-11-07