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

Model Number	482804740
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; screw head popped off during final tightening.The same size screw was used as a replacement with new blockers.
Additional Manufacturer Narrative
Method: risk assessment; result: the reported screw was not returned due to hospital policy, therefore, no device evaluation could be performed.The lot number was not provided, therefore, no complaint history review and device history review could be performed.The cause of event could not be determined.No impact to the patient, no delay and no adverse consequences were reported.
Event or Problem Description
It was reported that; screw head popped off during final tightening.The same size screw was used as a replacement with new blockers.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 7.5X40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7112473
• Report Number: 0009617544-2017-00433
• Device Sequence Number: 1799111
• Product Code: NKB
• UDI-Device Identifier: 07613327002225
• UDI-Public: (01)07613327002225
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

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: 482804740
• Device Catalogue Number: 482804740
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1