MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 EXTENDED CONNECTOR LARGE; PEDICLE SCREW SPINAL SYSTEM

Model Number	48135104
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the surgeon informed us that during a planned elongation check it was seen that the code was broken.The device was replaced during the surgery.The patient had no consequences due to the breakage and the elongation action had to be routinely performed.The date of the event is not reported.
Event or Problem Description
It was reported that; the surgeon informed us that during a planned elongation check it was seen that the code was broken.The device was replaced during the surgery.The patient had no consequences due to the breakage and the elongation action had to be routinely performed.The date of the event is not reported.

• Brand Name: XIA TITANIUM 4.5 EXTENDED CONNECTOR LARGE
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6667912
• Report Number: 0009617544-2017-00258
• Device Sequence Number: 985038
• Product Code: MNI
• UDI-Device Identifier: 04546540449597
• UDI-Public: (01)04546540449597
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060361
• 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): 08/25/2017

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: 48135104
• Device Catalogue Number: 48135104
• Device Lot Number: 137364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1