MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 90MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482318590
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	08/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after placement of the nail with blocker, the screw pulled out.The ring of the inner part of the screw had broken without loose of fragment.The surgical incision was washed.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment the reported event was confirmed via visual inspection.It was reported that the tulip disengaged while final tightening with the torque wrench and anti-torque key.The screw was returned in 2 pieces, with the tulip disengaged from the screw shank.The tulip locking ring and the screw shank bulb are deformed on one side, indicating that the screw was over angulated in one direction.The rod divot on the shank bulb is at an angle, indicating that the rod was seated at an angle inside of the tulip.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The surgical technique calls for the rod to be perpendicular to the screw when being seated into the rod.Additionally, the damage on the screw shows that the tulip was over angulated until it eventually disengaged.Conclusion: 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 placement of the nail with blocker, the screw pulled out.The ring of the inner part of the screw had broken without loose of fragment.The surgical incision was washed.There are no reports of adverse health consequences to the patient.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 90MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7924395
• Report Number: 3005525032-2018-00062
• Device Sequence Number: 1346218
• Product Code: NKB
• UDI-Device Identifier: 04546540598660
• UDI-Public: 04546540598660
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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: 482318590
• Device Lot Number: B77822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Initial Date Received by Manufacturer: 09/03/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1