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	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when trying to move the crosslink after placing it on the construct, it appears that either the hexdriver stripped or the locking screw stripped out.As a result, we had to remove the rod and manually slide the connector off the rod.Upon grabbing a replacement connector, it was found that the new connectors locking screw was cracked.The surgeons believe that may have been an issue with the first connector.".
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.No relevant manufacturing issues were identified as all units met specifications.The device was inspected and it was found that one of the set screws was fractured.The plausible root cause of the event is determined to be use error.
Event or Problem Description
It was reported that "when trying to move the crosslink after placing it on the construct, it appears that either the hexdriver stripped or the locking screw stripped out.As a result, we had to remove the rod and manually slide the connector off the rod.Upon grabbing a replacement connector, it was found that the new connectors locking screw was cracked.The surgeons believe that may have been an issue with the first 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: 6477515
• Report Number: 0009617544-2017-00134
• Device Sequence Number: 1289800
• Product Code: MNH
• UDI-Device Identifier: 04546540515094
• UDI-Public: (01)04546540515094
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K060748
• 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: 166172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: 03/13/2017
• Initial Report FDA Received Date: 04/10/2017
• 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