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

Model Number	48133480
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a follow up, the rod was broken.The broken rod was connected by rod connector as treatment.
Additional Manufacturer Narrative
Results: visual, dimensional and functional analysis could not be performed as the device was not provided and could not be obtained.No lot # was provided, so a manufacturing record review could not be performed.The root cause of the event cannot be determined with the given information.
Event or Problem Description
It was reported that during a follow up, the rod was broken.The broken rod was connected by rod connector as treatment.

• 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: 6827637
• Report Number: 0009617544-2017-00343
• Device Sequence Number: 10940567
• Product Code: KWP
• UDI-Device Identifier: 04546540449412
• UDI-Public: (01)04546540449412
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48133480
• Device Catalogue Number: 48133480
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR