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

Catalog Number 48230000

Device Problems Detachment of Device or Device Component (2907); Migration (4003)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device location unknown.

Event Description

A patient experienced a post-operative fall and imaging indicated that the rods were not retained by a xia 3 closed screw and a xia 3 connector.Revision surgery is planned.This report captures the xia 3 closed screw.

Event Description

It was reported that a patient experienced a post-operative fall approximately 45 days after an initial surgery for scoliosis.Imaging indicated that a rod had come loose from a xia 3 blocker.A few days later the patient suffered a second fall and imaging indicated that a second rod had come loose from a xia 3 offset connector.The patient complained of pain and underwent revision surgery whereby the two loosened rods were removed and replaced.This report captures the xia blocker.

• 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-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 17407286
• MDR Text Key: 319924138
• Report Number: 0009617544-2023-00059
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48230000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 61 YR
• Patient Sex: Female