XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM 48132601

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-08 for XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM 48132601 manufactured by Stryker Spine-us.

Event Text Entries

[102079699] It was reported that the rod broke.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0009617544-2018-00064
• MDR Report Key: 7323863
• Date Received: 2018-03-08
• Date of Report: 2018-05-25
• Date of Event: 2018-02-12
• Date Mfgr Received: 2018-04-27
• Date Added to Maude: 2018-03-08
• 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: PHYSICIAN ASSISTANT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. MARTA KOUTSOGIANNIS
• Manufacturer Street: 2 PEARL COURT
• Manufacturer City: ALLENDALE NJ 07401
• Manufacturer Country: US
• Manufacturer Postal: 07401
• Manufacturer Phone: 2017608000
• Manufacturer G1: STRYKER SPINE-FRANCE
• Manufacturer Street: ZONE INDUSTRIELLE DE MARTICOT
• Manufacturer City: CESTAS 33610
• Manufacturer Country: FR
• Manufacturer Postal Code: 33610
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM
• Generic Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.
• Product Code: OSH
• Date Received: 2018-03-08
• Model Number: 48132601
• Catalog Number: 48132601
• Lot Number: UNKNOWN
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER SPINE-US
• Manufacturer Address: 2 PEARL COURT ALLENDALE NJ 07401 US 07401

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2018-03-08