MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 480; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48133480
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Injury (2348)
Date of Event	10/22/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was a must for a patient that has fallen in the bathroom.Patient claimed severe pain due to the broken rods, and the revision surgery was recommended.The surgeon explants broken rods and replaced them with new one also extended connectors are replaced as well.
Additional Manufacturer Narrative
Visual inspection, risk assessment.The customer reported event was confirmed via visual inspection.No lot # was provided, so a manufacturing record review could not be performed.The excessive load due to the patient fall is the plausible root cause of the rod's fatigue fracture.
Event or Problem Description
It was reported that a revision surgery was a must for a patient that has fallen in the bathroom.Patient claimed severe pain due to the broken rods, and the revision surgery was recommended.The surgeon explants broken rods and replaced them with new one also extended connectors are replaced as well.

• Brand Name: XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 480
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6113410
• Report Number: 0009617544-2016-00467
• Device Sequence Number: 1360500
• Product Code: KWP
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2016
• Supplement Report FDA Received Date: 01/26/2017
• 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 Weight: 22