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

Catalog Number	48135103
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	02/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The device is reported to be broken after surgery.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: the ifu states, "once implanted, the implants are subjected to stresses and strains.Indeed, the stresses and strains on the implants may cause metal fatigue or fracture or deformation of the implants, before the bone graft has become completely consolidate." per email correspondence with the sales rep, it was reported that the patient did not fuse.A similar device was sent for material analysis and it was determined that the device experienced a fatigue fracture.Conclusion: the 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
The device is reported to be broken after surgery.

• Brand Name: XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5645538
• Report Number: 0009617544-2016-00179
• Device Sequence Number: 13488399
• Product Code: MNH
• UDI-Device Identifier: 04546540449580
• UDI-Public: (01)04546540449580
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2016

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: 114954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2016
• Supplement Report FDA Received Date: 07/28/2016
• 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