MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 35MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482365535
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During a pso and vcr surgery, three distal screws were tightened and one proximal screw.While compressing and tightening the screw in question, the tulip and screw shaft separated.The surgery was completed successfully using an alternate screw.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual inspection.The surgery was completed successfully with no delay.There was deformation on both the tulip head locking clip and the screw shank head, indicative of the tulip being overextended in one direction which caused it to disengage fully from the shank.This can happen if the rod is not fully seated into the tulip head (too high, too low, not horizontal, etc.).It was reported that the rod may not have been fully seated into the tulip due to patient's deformity.Additionally excessive compressive force applied can cause the tulip head to overextend in one direction and disengage.The surgical technique advises extra caution when the rod is not horizontally placed into the screw head, too high, or there is an acute convex or concave bend contoured into the rod.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The most likely root cause is determined to be user error as excessive force was applied.
Event or Problem Description
During a pso and vcr surgery, three distal screws were tightened and one proximal screw.While compressing and tightening the screw in question, the tulip and screw shaft separated.The surgery was completed successfully using an alternate screw.No adverse consequences to the patient were reported.

• Brand Name: XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 35MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7643355
• Report Number: 0009617544-2018-00159
• Device Sequence Number: 1652368
• Product Code: NKB
• UDI-Device Identifier: 07613327000900
• UDI-Public: (01)07613327000900
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• 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): 10/22/2018

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: 482365535
• Device Catalogue Number: 482365535
• Device Lot Number: 17E517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR