MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48236043
Medical Device Problem Codes	Disassembly (1168); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was using a multi-axial cross connector during a l5/s1 fixation case.While using the hex driver to advance the screw, one of the set screws came loose and detached from the cross connector.The surgeon was unable to reattach the screw and used a different multi-axial cross connector to complete the case.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: the returned set screw was confirmed to have been disengaged.However, the screw as able to be re-threaded onto the cross connector and function without issue.No relevant manufacturing issues were identified during manufacturing record review.Conclusion: the most likely cause of the customer reported event is unthreading of the set screw by the user, resulting in its disengagement.
Event or Problem Description
It was reported that the surgeon was using a multi-axial cross connector during a l5/s1 fixation case.While using the hex driver to advance the screw, one of the set screws came loose and detached from the cross connector.The surgeon was unable to reattach the screw and used a different multi-axial cross connector to complete the case.

• Brand Name: XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5514511
• Report Number: 0009617544-2016-00121
• Device Sequence Number: 1162174
• Product Code: MNH
• UDI-Device Identifier: 04546540560872
• UDI-Public: (01)04546540560872
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K071373
• 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): 02/24/2016

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 Catalogue Number: 48236043
• Device Lot Number: 158811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2016
• Supplement Report FDA Received Date: 06/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1