MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 480; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48133480
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	12/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient claimed back pain.After taking some graphics has been found out that the rod and the connector has been broken.First surgery was performed on (b)(6) 2014.Date of event: about 2 months before the revision date.Date of explant - (b)(6) 2016.The surgeons' opinion is that a fatigue fracture occurred for the rod but for the connector he has no idea about the reason of fracture.
Additional Manufacturer Narrative
Method: device evaluation, risk assessment; result: the rod was confirmed to be fractured during visual inspection.Conclusion: 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 the patient claimed back pain.After taking some graphics has been found out that the rod and the connector has been broken.First surgery was performed on (b)(6) 2014 date of event: about 2 months before the revision date.Date of explant - (b)(6) 2016.The surgeons' opinion is that a fatigue fracture occurred for the rod but for the connector he has no idea about the reason of fracture.

• Brand Name: XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 480
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6267816
• Report Number: 0009617544-2017-00016
• Device Sequence Number: 908046
• Product Code: NKB
• UDI-Device Identifier: 04546540449412
• UDI-Public: (01)04546540449412
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K050461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017

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: 48133480
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2017
• Supplement Report FDA Received Date: 04/12/2017
• 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 Age: 13 YR
• Patient Weight: 25