MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 48230000

Device Problem Migration (4003)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2022

Event Type  Injury  

Event Description

It was reported that a xia 3 blocker migrated from a xia serrato polyaxial screw at s2 approximately 1 year post-operatively.It is not known at this time if revision surgery has been scheduled or performed.This report captures the blocker.

Manufacturer Narrative

Status and location of the device is unknown.

Manufacturer Narrative

Fields b1, b2, d6b, and h1 have been updated to reflect revision surgery.H6 grids have been updated to reflect receipt of the device and completion of the investigation.

Event Description

It was reported that a xia 3 blocker migrated from a xia serrato polyaxial screw at s2 approximately 1 year post-operatively.Revision surgery has been performed.This report captures the blocker.

Event Description

It was reported that a xia 3 blocker migrated from a xia serrato polyaxial screw at s2 approximately 1 year post-operatively.It is not known at this time if revision surgery has been scheduled or performed.This report captures the blocker.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were identified.Initial report states that the left s2 screw set screw popped out [migrated] post-op.No images, x-rays, or products were received.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established with the information available.If additional information is received, the investigation will be reopened and updated.

• Brand Name: XIA 3 TITANIUM BLOCKER
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; SZ 2300
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14470887
• MDR Text Key: 292399855
• Report Number: 3005525032-2022-00012
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540560193
• UDI-Public: 04546540560193
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48230000
• Device Catalogue Number: 48230000
• Device Lot Number: YHH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 85 KG