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

Model Number	48133236
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during small surgery, the surgeon used the cross link connector.When the surgeon loosened the nut of one side of the connector, the nut was not loosened.Therefore the surgeon changed the connector to another same size connector.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment; visual, dimensional and functional analysis could not be performed as the device was not returned and lot was not provided.No relevant manufacturing issues were identified as all units met stryker specifications the plausible root cause of the event was determined to be use error.
Event or Problem Description
It was reported that; during small surgery, the surgeon used the cross link connector.When the surgeon loosened the nut of one side of the connector, the nut was not loosened.Therefore the surgeon changed the connector to another same size connector.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 36-45 MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6517332
• Report Number: 0009617544-2017-00164
• Device Sequence Number: 18956402
• Product Code: KWP
• UDI-Device Identifier: 04546540515094
• UDI-Public: (01)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): 07/20/2017

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: 48133236
• Device Catalogue Number: 48133236
• Device Lot Number: EF8
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1