MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 40MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482318540
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; tulip popped off screw when it was final tightened.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The device was inspected and it was confirmed that the tulip head was disengaged from the main screw body.Further inspection found the locking clip on the tulip head was deformed.Also the threading of the blocker seem to be deformed suggesting excessive torque applied to the blocker during final tightening.The surgical technique states do not use torque in excess of 12 nm.Conclusion: the possible cause of the event is determined to be user error- application of excessive torque for final tightening.
Event or Problem Description
It was reported that; tulip popped off screw when it was final tightened.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 40MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5762244
• Report Number: 3005525032-2016-00073
• Device Sequence Number: 10922522
• Product Code: MNH
• UDI-Device Identifier: 04546540598585
• UDI-Public: (01)04546540598585
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2016

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: 482318540
• Device Lot Number: B42330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2016
• Supplement Report FDA Received Date: 09/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 95