MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 90MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.

Model Number	482319590
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was final tightening the blocker on the pelvic screw, and the head of the screw popped off.The rod was seated in the lateral connector that was connected to the pelvic screw.He then removed the screw and replaced with another one.Delay in surgery of 10 minutes.No adverse consequences to the patient is reported.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via visual inspection.The screw was returned in 2 pieces with the tulip disengaged from the main screw shank.There was deformation on the tulip locking ring and the head of the screw shank.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was reported that excessive and cantilever force was not applied and 12nm was applied to the blocker, but the anti torque key was not used.It is stated in the surgical technique that "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 and helps to maximize the torque needed to lock the implant assembly." conclusion: the most likely root cause is the anti torque key was not used during final tightening as outlined in the surgical technique.
Event or Problem Description
It was reported that the surgeon was final tightening the blocker on the pelvic screw, and the head of the screw popped off.The rod was seated in the lateral connector that was connected to the pelvic screw.He then removed the screw and replaced with another one.Delay in surgery of 10 minutes.No adverse consequences to the patient is reported.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 90MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• MDR Report Key: 7318822
• Report Number: 3005525032-2018-00007
• Device Sequence Number: 151321
• Product Code: NKB
• UDI-Device Identifier: 04546540598868
• UDI-Public: (01)04546540598868
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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: No Information
• Device Model Number: 482319590
• Device Catalogue Number: 482319590
• Device Lot Number: B70633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1