MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482317545
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	06/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon was removing a screw, the tulip came off of the screw.The surgery was successfully completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, product history review, labelling review, risk assessment, complaint history review result: the customer reported event was confirmed via visual inspection.The surgery was completed successfully with no surgical delay.The device was returned in 2 pieces as the tulip head was disengaged from the screw shank.There was deformation on the bottom of the tulip head and on the head of the screw shank on one side of the implant.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was reported that the screw tulip disengaged as it was removed during a revision surgery to extend the construct up a level.The surgeon used the screwdriver and did not appear to apply excessive force nor was the angle difficult.Conclusion: the damage shown on the screw can be caused by applying off axis loading to the implant, such as bending the screw in one direction during removal.It is also possible that length of implantation played a role, as according to the ifu, "metallic implants can loosen, bend, fracture, corrode, migrate, cause pain or stress shield bone." it is possible the tulip head loosened over time during implantation and once force was applied to remove it, it disengaged.
Event or Problem Description
It was reported that when the surgeon was removing a screw, the tulip came off of the screw.The surgery was successfully completed with no adverse consequences to the patient.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7700459
• Report Number: 3005525032-2018-00048
• Device Sequence Number: 16344954
• Product Code: NKB
• UDI-Device Identifier: 04546540562357
• UDI-Public: 04546540562357
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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: Health Professional
• Device Catalogue Number: 482317545
• Device Lot Number: A80217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1