MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	03829650
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	06/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021 a patient was implanted with a l5-s1 tlif.When repositioning the left l5 screw, the tulip head of the left s1 screw came off.The left s1 screw was successfully removed and replaced.The procedure was completed successfully with an unknown amount of surgical delay.No adverse consequences resulted from this event.
Additional Manufacturer Narrative
Visual inspection was performed and confirmed that the tulip disengaged from the screw shank.There is deformation on the base of the tulip, indicating excessive force was applied to tulip during final tightening.The deformation observed on the screw shank bulb indicates that the shank was at a high angulation during final tightening as well.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.The xia surgical technique guide was reviewed and the following was found relevant: use the anti-torque key and the torque wrench or audible torque wrench to final tighten the blockers.The anti-torque key must be used for final tightening.The anti-torque key performs two key functions: ¿ allows the torque wrench to align with the tightening axis.¿ helps to maximize the torque needed to lock the implant assembly.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.If using the audible torque wrench, the blocker is completely tightened to 12nm when the audible torque wrench clicks once.Extra caution is advised in the following cases: ¿ the rod is not horizontally placed into the screw head.¿ the rod is high in the screw head.¿ an acute convex or concave bend is contoured into the rod.Due to the deformation observed on the tulip head and screw shank bulb, the most likely cause of the reported event was determined to be excessive torque during final tightening.The blocker fracture observed also indicates excessive torque was applied to the blocker.This excessive torque may damage/deform the tulip head which can contribute to the reported event.
Event or Problem Description
It was reported that a patient was implanted with a l5-s1 tlif.When repositioning the left l5 screw, the tulip head of the left s1 screw came off.The left s1 screw was successfully removed and replaced.The procedure was completed successfully with an unknown amount of surgical delay.No adverse consequences resulted from this event.This record captured the xia deformity polyaxial screw.

• Brand Name: XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 50MM
• 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: 12206730
• Report Number: 0009617544-2021-00128
• Device Sequence Number: 4440460
• Product Code: NKB
• UDI-Device Identifier: 07613154407903
• UDI-Public: 07613154407903
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K061854
• 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): 11/10/2021

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: 03829650
• Device Catalogue Number: 03829650
• Device Lot Number: 145223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2014
• 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: Male
• Patient Weight: 216 KG