MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 36-45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48133236
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two xia titanium 4.5 polyaxial cross connector securing mechanisms jammed intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.This report represents the second of two cross connectors.
Event or Problem Description
It was reported that two xia titanium 4.5 polyaxial cross connector securing mechanisms jammed intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.This report represents the second of two cross connectors.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.As the device was not returned, a definite root cause cannot be determined.Possible root causes include connector in the wrong location or off- axis, hex disengagement due to cantilever force, non optimal screw placement, poor rod bending and/or hex screw initially torqued in the wrong direction.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 36-45 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: 10072861
• Report Number: 0009617544-2020-00070
• Device Sequence Number: 3696627
• Product Code: NKB
• UDI-Device Identifier: 04546540515094
• UDI-Public: 04546540515094
• Combination Product (Y/N): N
• PMA/510(K) Number: K121342
• 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): 09/23/2020

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 Model Number: 48133236
• Device Catalogue Number: 48133236
• Device Lot Number: 1867700
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1