MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 35 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482317535
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	09/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; when the screw was removed during surgery, the tulip head was stuck.Therefore, the screw was removed with kochel.Update (b)(6): when the surgeon was performed final tightening of screw, the anti torque key came off from the screw and the screw hole thread was broken.Therefore, the screw was removed.
Additional Manufacturer Narrative
Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual inspection showed the threads were found to be deformed which can be indicative of blocker misalignment or cross threading.Conclusion: the plausible root cause of the event is determined to be use error- misalignment of the blocker and the tulip.
Event or Problem Description
It was reported that; when the screw was removed during surgery, the tulip head was stucked.Therefore, the screw was removed with kochel.Update 10/16/2017: when the surgeon was performed final tightening of screw, the anti torque key came off from the screw and the screw hole thread was broken.Therefore, the screw was removed.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 35 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6954567
• Report Number: 0009617544-2017-00378
• Device Sequence Number: 10942261
• Product Code: MNI
• UDI-Device Identifier: 04546540562333
• UDI-Public: (01)04546540562333
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• 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): 12/21/2017

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: 482317535
• Device Catalogue Number: 482317535
• Device Lot Number: B67251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1