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

Model Number	482317540
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported that the tulip of a xia 3 polyaxial screw broke off from the screw shaft post-operatively.Revision surgery has not been scheduled or performed at this time.
Event or Problem Description
It was reported that the tulip of a xia 3 polyaxial screw broke off from the screw shaft post-operatively.Revision surgery has not been scheduled or performed at this time.
Additional Manufacturer Narrative
The device remains implanted and therefore unavailable for evaluation.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number and no adverse trends were identified.The event of tulip disengagement was confirmed via imaging provided by the reported physician.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A definitive root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14547556
• Report Number: 0009617544-2022-00058
• Device Sequence Number: 5171982
• Product Code: NKB
• UDI-Device Identifier: 04546540562340
• UDI-Public: 04546540562340
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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 Model Number: 482317540
• Device Catalogue Number: 482317540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female