MAUDE Adverse Event Report: STRYKER SPINE-US XIA LP POLYAXIAL SCREW 6.5 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	03821640
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during rotation of the xia ll polyaxial screw the tulip head of the screw came out of the shaft intra-operatively.No adverse consequences were reported.Surgery was successfully completed with a 10 minute delay.
Additional Manufacturer Narrative
Visual inspection confirmed that tulip head disengaged from shank.There are multiple deformation marks on bottom of tulip head and slight indentation on screw shank head.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Device ifu was reviewed and the following was found to be relevant: "the doctor operating must take care not to use the instruments to exert inappropriate stress on the spine or the implants and must scrupulously comply with any operating procedure described in the surgical technique provided by stryker spine.For example, the forces exerted when repositioning an instrument in-situ must not be excessive as this is likely to causes injury to the patient".The most likely cause of the reported event was determined to be excessive force applied during spinal correction maneuvers.
Event or Problem Description
It was reported that during rotation of the xia ll polyaxial screw the tulip head of the screw came out of the shaft intra-operatively.No adverse consequences were reported.Surgery was successfully completed with a 10 minute delay.

• Brand Name: XIA LP POLYAXIAL SCREW 6.5 X 40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11667374
• Report Number: 3005525032-2021-00015
• Device Sequence Number: 3127908
• Product Code: NKB
• UDI-Device Identifier: 04546540149237
• UDI-Public: 04546540149237
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: 03821640
• Device Catalogue Number: 03821640
• Device Lot Number: C01044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1