MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM MULTIAXIAL CROSSLINK 53MM 73MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48236053
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	07/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported; during surgery, when the surgeon placed the connector and tightened the central nut the nut broke.The surgeon used a spare one.
Additional Manufacturer Narrative
Visual inspection; material analysis; device history review; complaint history review; risk assessment; no relevant manufacturing issues were identified as all units met specifications.Material analysis was performed and it was found that the center bolt was found to have fractured in ductile overload.The most likely root cause is excessive force applied by the user.
Event or Problem Description
It was reported; during surgery, when the surgeon placed the connector and tightened the central nut the nut broke.The surgeon used a spare one.

• Brand Name: XIA 3 TITANIUM MULTIAXIAL CROSSLINK 53MM 73MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5858358
• Report Number: 0009617544-2016-00325
• Device Sequence Number: 1163339
• Product Code: MNH
• UDI-Device Identifier: 04546540560889
• UDI-Public: (01)04546540560889
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2016

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: 48236053
• Device Lot Number: 144801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2016
• Supplement Report FDA Received Date: 10/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR