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	07/01/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; x primary surgery was performed on (b)(6) 2012.Th5-s2ai were fixed.After that revision surgery was performed on (b)(6) 2014 due to a rod breakage.In the revision, the bone graft has been subjected and five rods were used for fixation.This event is related to (b)(4).
Additional Manufacturer Narrative
Risk assessment; no product was returned and lot number was not provided, therefore device inspection, device history review and complaint history review could not be performed.According to the instructions for use, the implants are subjected to stresses and strains once implanted.While the expected life of spinal implant components is difficult to estimate, it is finite.Without the device inspection and further information the root cause cannot be determined conclusively.
Event or Problem Description
It was reported that; x primary surgery was performed on (b)(6) 2012.Th5-s2ai were fixed.After that revision surgery was performed on (b)(6) 2014 due to a rod breakage.In the revision, the bone graft has been subjected and five rods were used for fixation.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: 5766312
• Report Number: 0009617544-2016-00266
• Device Sequence Number: 16144107
• 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
• Device Explanted Year: 2014
• 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