MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48135103
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/08/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; removal of broken rod extender.
Additional Manufacturer Narrative
Lot# 116764; visual inspection; device history review; complaint history review; risk assessment; it was found that the connector was fractured where the main shaft meets the threaded body.The fracture goes around the shaft, but the two pieces are still attached to each other.A material analysis was performed on a similar complaint.The analysis confirmed that the returned connector and rod experienced fatigue fractures.No material or manufacturing defects were observed on the surfaces examined.The most likely cause of the reported event is most likely 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; removal of broken rod extender.

• Brand Name: XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5842789
• Report Number: 0009617544-2016-00321
• Device Sequence Number: 270458
• Product Code: KWP
• UDI-Device Identifier: 04546540449580
• UDI-Public: (01)04546540449580
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121342
• 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): 07/08/2016

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: 48135103
• Device Lot Number: 116764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 10/24/2016
• 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