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

Model Number 48230000

Device Problems Material Deformation (2976); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

It was reported that a serrato reduction polyaxial screw tulip and the threads of two xia 3 titanium blockers deformed intra-operatively.While tightening the blocker on the reduction screw, the surgeon heard the sound of the tab of the universal tightener breaking.It was discovered that the thread of the screw head was deformed and the blocker was cross threaded.The blocker was not able to be installed in the correct position.The surgeon was able to complete the procedure successfully by replacing the screw and blockers with new ones.There were no adverse consequences with the patient and no surgical delay.This report represents the second of the two blockers.

Manufacturer Narrative

The device was visually inspected and no device deformation was observed.The reported event of deformation cannot be confirmed.There is no product malfunction associated with this device.

Event Description

It was reported that a serrato reduction polyaxial screw tulip and the threads of two xia 3 titanium blockers deformed intra-operatively.While tightening the blocker on the reduction screw, the surgeon heard the sound of the tab of the universal tightener breaking.It was discovered that the thread of the screw head was deformed and the blocker was cross threaded.The blocker was not able to be installed in the correct position.The surgeon was able to complete the procedure successfully by replacing the screw and blockers with new ones.There were no adverse consequences with the patient and no surgical delay.Additional review of the devices indicates that only one of the two blockers was deformed.This record represents the blocker which was not deformed.

• 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
• MDR Report Key: 10485587
• MDR Text Key: 205476032
• Report Number: 0009617544-2020-00146
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540560193
• UDI-Public: 04546540560193
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48230000
• Device Catalogue Number: 48230000
• Device Lot Number: 2Z4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1