MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE L 7.5X40MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482804740
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	02/09/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was required to replace the rod that migrated.
Additional Manufacturer Narrative
No methods performed.Concomitant product no results available because no method was performed.Concomitant product no product issue related to the reported event was found with this product, so this is a concomitant product.
Event or Problem Description
It was reported that a revision surgery was required to replace the rod that migrated.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 7.5X40MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5480364
• Report Number: 0009617544-2016-00092
• Device Sequence Number: 13582550
• Product Code: NKB
• UDI-Device Identifier: 07613327002225
• UDI-Public: 07613327002225
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122845
• 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): 02/09/2016

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: 482804740
• Device Lot Number: 151473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2016
• Supplement Report FDA Received Date: 05/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR