STAYFUSE FUSION SYSTEM STA-D7

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-11-06 for STAYFUSE FUSION SYSTEM STA-D7 manufactured by Nexa Orthopedics, Inc..

Event Text Entries

[534615] Pt complained of clawing in 1st & 2nd digits of foot. Surgeon elected to remove implants from 1st and 2nd digits.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2030833-2006-00010
• MDR Report Key: 778862
• Report Source: 05,07
• Date Received: 2006-11-06
• Date of Report: 2006-11-06
• Date of Event: 2006-08-29
• Date Mfgr Received: 2006-09-05
• Date Added to Maude: 2006-11-13
• 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: 0
• Manufacturer Street: 10675 SORRENTO VALLEY RD #100
• Manufacturer City: SAN DIEGO CA 92121
• Manufacturer Country: US
• Manufacturer Postal: 92121
• Manufacturer Phone: 8588660660
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STAYFUSE FUSION SYSTEM
• Generic Name: INTERPHALANGEAL FUSION DEVICE
• Product Code: LZJ
• Date Received: 2006-11-06
• Returned To Mfg: 2006-10-05
• Model Number: STA-D7
• Catalog Number: STA-D7
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 766640
• Manufacturer: NEXA ORTHOPEDICS, INC.
• Manufacturer Address: * SAN DIEGO CA * US
• Baseline Brand Name: STAYFUSE FUSION SYSTEM
• Baseline Generic Name: INTERPHELANGEAL FUSION DEVICE
• Baseline Model No: STA-D7
• Baseline Catalog No: STA-D7
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2006-11-06