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

Catalog Number	03822601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	06/07/2016
Type of Reportable Event	Serious Injury
Event or Problem 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).
Additional 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 or Problem 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
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5766291
• Report Number: 0009617544-2016-00267
• Device Sequence Number: 506252
• Product Code: KWP
• UDI-Device Identifier: 04546540539656
• UDI-Public: (01)04546540539656
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2016

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: 03822601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2016
• Supplement Report FDA Received Date: 10/20/2016
• 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
• Patient Age: 70 YR