INNOVASIS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-25 for INNOVASIS * manufactured by Innovasis.

Event Text Entries

[2218426] During a follow-up, post surgery appointment, patient explained he was having an increase of pain. X-rays showed failed implants from the implant surgery -- the set screws were dislodged from the pedicle screws, except the right s1 screw and the rods had come out of the pedicle screw tulips. Patient had a second surgery to remove failed implants and place new ones.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2313033
• MDR Report Key: 2313033
• Date Received: 2011-10-25
• Date of Report: 2011-10-25
• Date of Event: 2011-08-23
• Report Date: 2011-10-25
• Date Reported to FDA: 2011-10-25
• Date Added to Maude: 2011-10-28
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: INNOVASIS
• Generic Name: 7.5 X 50 SCREW (2)
• Product Code: HWC
• Date Received: 2011-10-25
• Model Number: *
• Catalog Number: *
• Lot Number: 1001
• ID Number: *
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INNOVASIS
• Manufacturer Address: 614 EAST 3900 SOUTH SALT LAKE CITY UT 84107 US 84107

Device Sequence Number: 2

• Brand Name: INNOVASIS
• Generic Name: 7.5 X 55 SCREW (2)
• Product Code: HWC
• Date Received: 2011-10-25
• Model Number: *
• Catalog Number: *
• Lot Number: 0802
• ID Number: *
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: INNOVASIS
• Manufacturer Address: 614 EAST 3900 SOUTH SALT LAKE CITY UT 84107 US 84107

Device Sequence Number: 3

• Brand Name: INNOVASIS
• Generic Name: LOCKING CAP POLYAXIAL (4)
• Product Code: JDT
• Date Received: 2011-10-25
• Model Number: *
• Catalog Number: *
• Lot Number: 1101
• ID Number: *
• Device Availability: Y
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: INNOVASIS
• Manufacturer Address: 614 EAST 3900 SOUTH SALT LAKE CITY UT 84107 US 84107

Device Sequence Number: 4

• Brand Name: INNOVASIS
• Generic Name: CROSS CONNECTOR 50-60
• Product Code: MNI
• Date Received: 2011-10-25
• Model Number: *
• Catalog Number: *
• Lot Number: 1002
• ID Number: *
• Device Availability: Y
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: INNOVASIS
• Manufacturer Address: 614 EAST 3900 SOUTH SALT LAKE CITY UT 84107 US 84107

Device Sequence Number: 5

• Brand Name: INNOVASIS
• Generic Name: 6MM X 55 MM ROD
• Product Code: JDN
• Date Received: 2011-10-25
• Model Number: *
• Catalog Number: *
• Lot Number: 0901
• ID Number: *
• Device Availability: Y
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: INNOVASIS
• Manufacturer Address: 614 EAST 3900 SOUTH SALT LAKE CITY UT 84107 US 84107

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-10-25