MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 70MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482318570
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
When final tightening the xia 3 iliac poly screw, 8x5 x 70mm, the head popped off the screw.The screw was removed and replaced with a 9.5 x 70mm screw.The procedure was completed successfully with a 15 minute delay and the patient was unharmed.
Event or Problem Description
When final tightening the xia 3 iliac poly screw, 8x5 x 70mm, the head popped off the screw.The screw was removed and replaced with a 9.5 x 70mm screw.The procedure was completed successfully with a 15 minute delay and the patient was unharmed.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained since the device associated with this event was not returned.From the xia 3 surgical technique: once the correction procedures have been carried out and the spine is fixed in a satisfactory position, the final tightening of the blockers is performed.Use the anti-torque key and the torque wrench.The anti-torque key and torque wrench come in two sizes; standard and short.The short torque wrench will not fit through the standard antitorque key.Place the anti-torque key around the screw head.Place the torque wrench through the anti-torque key until it is guided into the blocker.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Line up the two arrows to achieve the final tightening torque of 12nm.Do not exceed 12nm during final tightening.There is not enough information available to determine a root cause.Possible root causes include excessive torque applied, excessive cantilever force applied, overangulation, rod not fully seated, and/or improper screw hole prep.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 70MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9372081
• Report Number: 3005525032-2019-00088
• Device Sequence Number: 14169664
• Product Code: NKB
• UDI-Device Identifier: 04546540598646
• UDI-Public: 04546540598646
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 482318570
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1