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

Model Number 48230000

Device Problem Migration (4003)

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

Event Date 09/05/2022

Event Type  Injury  

Event Description

It was reported that a patient was revised to address two migrated xia 3 blockers approximately three months after implantation.This report captures the first of the two migrated blockers.

Manufacturer Narrative

Fda registration number is 3005525032 spine (switzerland).H6 codes have been updated to reflect conclusion of the investigation.H3 other text: no product returned.

Event Description

It was reported that a patient was revised to address two migrated xia 3 blockers approximately three months after implantation.This report captures the first of the two migrated blockers.

• Brand Name: XIA 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: 15514785
• MDR Text Key: 300886905
• Report Number: 0009617544-2022-00091
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540560193
• UDI-Public: 04546540560193
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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: 03756230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 52 YR
• Patient Sex: Male