MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482316545
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.
Event or Problem Description
It was reported that 4 xia 3 titanium polyaxial screws were loose and migrated post-operatively.Revision surgery has been performed and the screws explanted.This report represents the second of the 4 xia 3 titanium polyaxial screws.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.'per the xia ifu: while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.Loosening of spinal fixation implants can occur.Late loosening may result from trauma, infection, biological complications or mechanical problems, with the subsequent possibility of bone erosion, migration and/or pain'.The screws were implanted for over four years.Lack of fusion, trauma and excessive post-op activity level beyond surgeon recommendation among other factors indicated in the ifu may have contributed to the migration.However, the exact cause of the reported event cannot be determined conclusively from the information provided and without device evaluation.H3 other text: device was not returned.
Event or Problem Description
It was reported that 4 xia 3 titanium polyaxial screws were loose and migrated post-operatively.Revision surgery has been performed and the screws explanted.This report represents the second of the 4 xia 3 titanium polyaxial screws.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11269667
• Report Number: 0009617544-2021-00012
• Device Sequence Number: 1219178
• Product Code: NKB
• UDI-Device Identifier: 04546540562241
• UDI-Public: 04546540562241
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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
• Operator of Device: Health Professional
• Device Model Number: 482316545
• Device Catalogue Number: 482316545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention