MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 482317540S

Device Problem Material Separation (1562)

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

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

Disposed of by hospital.

Event Description

It was reported that the tulip of a xia 3 polyaxial screw disengaged from the shaft intra-operatively.No adverse consequences, or medical intervention were reported.The procedure was completed successfully with an unknown surgical delay.

Manufacturer Narrative

Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Since the device was not returned, an exact cause of the reported event could not be determined.It is likely that the tulip disengaged due to cantilever force applied while removing blocker/ adjusting rod during the surgery.

Event Description

It was reported that the tulip of a xia 3 polyaxial screw disengaged from the shaft intra-operatively.No adverse consequences, or medical intervention were reported.The procedure was completed successfully with an unknown surgical delay.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11872850
• MDR Text Key: 252348499
• Report Number: 0009617544-2021-00087
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 482317540S
• Device Lot Number: B85609
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1