MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 90MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482319590
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; we were trying to tighten down a blocker.When we attempted to distract and then tighten the blocker the blocker would become cross threaded apron re tightening.I believe the tulip head of the screw became splayed.We removed the screw and replaced it and were able to finish the case.
Additional Manufacturer Narrative
The reported event was confirmed via correspondence.Visual, dimensional and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.The root cause of the event was determined to be user error, specifically application of excessive torque and not using anti torque key on a cross threaded blocker leading to tulip splaying.
Event or Problem Description
It was reported that; we were trying to tighten down a blocker.When we attempted to distract and then tighten the blocker the blocker would become cross threaded apron re tightening.I believe the tulip head of the screw became splayed.We removed the screw and replaced it and were able to finish the case.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 90MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6852704
• Report Number: 3005525032-2017-00091
• Device Sequence Number: 656182
• Product Code: MNH
• UDI-Device Identifier: 04546540598868
• UDI-Public: (01)04546540598868
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083393
• 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): 11/30/2017

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: 482319590
• Device Catalogue Number: 482319590
• Device Lot Number: BO1113
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR