MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 80MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482319580
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after placing the nail with blocker, the screw head pull out was noticed.No adverse consequences to the patient has been reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the customer reported event was confirmed via visual inspection.The screw was returned in 2 pieces as the tulip was disengaged from the screw shank.The locking ring and the screw shank head were both deformed, indicating that the tulip head was over angulated in one direction until it eventually disengaged.Rod divot on the screw shank head indicates that the rod was not fully perpendicular with the screw when final tightening occurred.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The screw showed signs of tulip over angulation and suboptimal rod placement.The rod marking on the screw was at an angle, which is caused when the rod is seated in the tulip at an angle.The surgical technique calls for the rod to be perpendicular to the screw when being seated into the rod.The most likely root cause is the position of the rod caused additional torque to be applied to the screw which eventually caused the tulip to disengage.
Event or Problem Description
It was reported that after placing the nail with blocker, the screw head pull out was noticed.No adverse consequences to the patient has been reported.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 80MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7898487
• Report Number: 3005525032-2018-00058
• Device Sequence Number: 16564967
• Product Code: NKB
• UDI-Device Identifier: 04546540598745
• UDI-Public: 04546540598745
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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 Catalogue Number: 482319580
• Device Lot Number: B77154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1