MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM TRANSVERSE PROCESS HOOK LEFT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48230233
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
A physician reported that while attempting to install a xia 3 titanium transverse process hook on the left t11, the patient's transverse process broke.The physician altered their surgical plan and the operation was completed successfully using a pedicle screw.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.From the xia 3 stg: there are two options for preparing the site and inserting the hook: option 1: a horizontal window is created by excising the ligamentum flavum combined with the limited osteotomy of the edge of the lamina.The window is prepared large enough to accommodate the blade of the hook to be inserted.The blade is then turned 90° and seated on the lamina.Option 2: a squared window is created by opening the ligamentum flavum in conjunction with the limited laminotomy.A lamina preparer may be used with great care to dissect the ligamentum flavum.The hook is inserted in a downward rotational movement so that the tip of the blade hugs the anterior surface of the lamina at all times.Note: a gentle burring of the lamina is sometimes necessary to ease the access to the canal.As the device was not returned, a definite root cause cannot be determined.From the rep, it is possible excessive force was applied when installing the rod that could have contributed to the event.Other possible root causes include unintended bending/cantilever force applied during hook insertion, insufficient preparation for hook installment, incorrect instrument used, incorrect path/window created, and/or deformed/damaged blade tip.H3 other text : device was discarded by the site.
Event or Problem Description
A physician reported that while attempting to install a xia 3 titanium transverse process hook on the left t11, the patient's transverse process broke.The physician altered their surgical plan and the operation was completed successfully using a pedicle screw.

• Brand Name: XIA 3 TITANIUM TRANSVERSE PROCESS HOOK LEFT
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9934170
• Report Number: 0009617544-2020-00056
• Device Sequence Number: 2496996
• Product Code: NKB
• UDI-Device Identifier: 04546540560407
• UDI-Public: 04546540560407
• Combination Product (Y/N): N
• PMA/510(K) Number: K142381
• 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): 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 48230233
• Device Catalogue Number: 48230233
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 05/30/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other