MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 EXTENDED CONNECTOR LARGE; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48135104
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	10/16/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after 6 months from the date of the last rod lengthening surgery the growing connector has been broken.Surgeon did a revision surgery and replaced the item with a non-stryker product.Surgeon's opinion - fracture is caused by fatigue.
Additional Manufacturer Narrative
(b)(6).Date of implant: (b)(6) 2012.Visual inspection, device history review, complaint history review, risk assessment.The device was inspected and it was found returned in 2 pieces.No relevant manufacturing issues were identified as all units met stryker specifications.The most likely cause of the reported event is the configuration of the construct creating a large bending moment, which created repeated loads over time on a localized area and lead to the eventual fatigue fracture of the connector.
Event or Problem Description
It was reported that after 6 months from the date of the last rod lengthening surgery the growing connector has been broken.Surgeon did a revision surgery and replaced the item with a non-stryker product.Surgeon's opinion - fracture is caused by fatigue.

• Brand Name: XIA TITANIUM 4.5 EXTENDED CONNECTOR LARGE
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6074095
• Report Number: 0009617544-2016-00441
• Device Sequence Number: 16365753
• Product Code: MNH
• UDI-Device Identifier: 04546540449597
• UDI-Public: (01)04546540449597
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K052761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48135104
• Device Lot Number: 090015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2016
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 30