MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 40MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	482318540
Medical Device Problem Codes	Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital retained device.
Event or Problem Description
It was reported that the tulip of a xia 3 titanium polyaxial screw at s1 disengaged 2 months post-operatively.Upon revision, the surgeon found the tulip of the screw to have broken off from the screw threads.
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.Due to a lack of information and the device not being returned, the root cause of the reported event can not be determined.Potential root causes include: user error (unstable construct); incorrect or small-sized screws implanted; poor bone quality of patient; patient experiences a fall or trauma post-surgery; high activity level of patient post-surgery.
Event or Problem Description
It was reported that the tulip of a xia 3 titanium polyaxial screw at s1 disengaged 2 months post-operatively.Upon revision, the surgeon found the tulip of the screw to have broken off from the screw threads.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 40MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11455195
• Report Number: 3005525032-2021-00009
• Device Sequence Number: 11542591
• Product Code: NKB
• UDI-Device Identifier: 04546540598585
• UDI-Public: 04546540598585
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 482318540
• Device Catalogue Number: 482318540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 05/30/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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