MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48232600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	01/04/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2015, the patient underwent primary surgery with spinal fixation rods.After surgery, when the patient tried to carry a heavy baggage, rod in one side broke.Another day, when the patient bent forward, the rod in one side broke.Therefore, the patient underwent the revision surgery on (b)(6) 2016.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the returned was confirmed to be fractured upon visual inspection.No relevant manufacturing issues were identified as all released units met stryker specifications.Conclusion: the most likely cause of the event is fatigue of the devices due to the length of implantation.
Event or Problem Description
It was reported that on (b)(6) 2015, the patient underwent primary surgery with spinal fixation rods.After surgery, when the patient tried to carry a heavy baggage, rod in one side broke.Another day, when the patient bent forward, the rod in one side broke.Therefore, the patient underwent the revision surgery on (b)(6) 2016.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5439406
• Report Number: 0009617544-2016-00059
• Device Sequence Number: 273556
• Product Code: KWP
• UDI-Device Identifier: 04546540560582
• UDI-Public: 04546540560582
• Combination Product (Y/N): N
• PMA/510(K) Number: K071373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2016

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: 48232600
• Device Lot Number: JD3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2016
• Supplement Report FDA Received Date: 05/03/2016
• 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: 52 YR