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

Catalog Number	48236043
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; attempted to connect and rod by the nut driver, the middle of screw was broken.Replaced another screw and implanted.Complete the procedure.
Additional Manufacturer Narrative
Device history review, complaint history review, risk assessment.The device was not returned from the site, and it unavailable for evaluation, so visual, functional, and dimensional inspection could not be performed.No relevant manufacturing issues were identified as all units met stryker specifications.There is not enough information available to conclusively determine a root cause.
Event or Problem Description
It was reported that; attempted to connect and rod by the nut driver, the middle of screw was broken.Replaced another screw and implanted.Complete the procedure.

• 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: 6305928
• Report Number: 0009617544-2017-00050
• Device Sequence Number: 16404508
• Product Code: MNI
• UDI-Device Identifier: 04546540560872
• UDI-Public: (01)04546540560872
• Combination Product (Y/N): N
• 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): 05/15/2017

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 Catalogue Number: 48236043
• Device Lot Number: 165159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1