MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 90 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482317590

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Insert (1316); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 11/16/2017

Event Type  malfunction  

Event Description

It was reported that; during screw insertion, the screw head broke off the shaft.

Event Description

It was reported that; during screw insertion, the screw head broke off the shaft.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 90 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7124456
• MDR Text Key: 95459404
• Report Number: 0009617544-2017-00436
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 04546540562418
• UDI-Public: (01)04546540562418
• Combination Product (y/n): N
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 482317590
• Device Catalogue Number: 482317590
• Device Lot Number: B06534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1