MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 4.5 X 50 VITALLIUM PREBENT AND PRECUT ROD W/OUT HEX; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	481322050
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the original surgery was performed on (b)(6) 2015.Patient was relatively active.Following complaint of pain from the patient, it was discovered that the rod came out of the top screw of l3.

• Brand Name: XIA 4.5 X 50 VITALLIUM PREBENT AND PRECUT ROD W/OUT HEX
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5439623
• Report Number: 0009617544-2016-00063
• Device Sequence Number: 18952269
• Product Code: MNH
• UDI-Device Identifier: 07613327003383
• UDI-Public: 07613327003383
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K050461
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 481322050
• Device Lot Number: FK6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2016
• Initial Report FDA Received Date: 02/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR