MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482318550

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported that the tulip of a xia 3 titanium polyaxial screw at l4 disengaged less than a month post-operatively.Revision surgery is not scheduled at this time.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.No further investigation can be performed due to insufficient information provided.If more information is received and/or devices are returned for evaluation this investigation will be reopened and updated.

Event Description

It was reported that the tulip of a xia 3 titanium polyaxial screw at l4 disengaged less than a month post-operatively.Revision surgery is not scheduled at this time.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 50MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10742591
• MDR Text Key: 213478885
• Report Number: 3005525032-2020-00042
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540598608
• UDI-Public: 04546540598608
• Combination Product (y/n): N
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

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: Health Professional
• Device Model Number: 482318550
• Device Catalogue Number: 482318550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1