MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA II VITALIUM ROD 6.0 MM X 600 MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 03822601

Device Problems Break (1069); Fracture (1260); Difficult to Remove (1528); Material Deformation (2976)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 06/07/2016

Event Type  Injury  

Event Description

It was reported that; the second revision surgery was performed due to the rod breakage.The left and right of the rod were broke in two levels (left: l4/5 and l3/4, right: l5/s1 and l4/5).During the revision surgery, the surgeon tried to remove the closed polyaxial screw on left s2ai.But the screw was not able to removed and the tip of the drivers was deformed.The screw shaft was remained.This event is related to (b)(4).

Manufacturer Narrative

Method: risk assessment; result: no lot # was provided, so a manufacturing record review could not be performed.The product is not returned for evaluation and material analysis.The surgical technique for xia states " do not exceed 12nm during final tightening." excessive force applied and over tightening screws during final tightening could lead to excessive stress on the construct which could lead to stress concentration leading to rod fracture post- op.Conclusion: the definitive cause of the event could not be determined with the given information.

Event Description

It was reported that; the second revision surgery was performed due to the rod breakage.The left and right of the rod were broke in two levels (left : l4/5 and l3/4, right : l5/s1 and l4/5).During the revision surgery, the surgeon tried to remove the closed polyaxial screw on left s2ai.But the screw was not able to removed and the tip of the drivers was deformed.The screw shaft was remained.This event is related to (b)(4).

• Brand Name: XIA II VITALIUM ROD 6.0 MM X 600 MM
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5766291
• MDR Text Key: 48684228
• Report Number: 0009617544-2016-00267
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 04546540539656
• UDI-Public: (01)04546540539656
• Combination Product (y/n): N
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 03822601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR