MAUDE Adverse Event Report: STRYKER SPINE-FRANCE FIXED ANGLE BONE SCREW DIAM 4.0 X 14MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.

Model Number	48674014
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the screw from initial procedure backed out.Surgeon performed revision procedure to remove the screw and replace with revision screw.
Additional Manufacturer Narrative
Method: risk assessment; the reported event was confirmed visually to have backed out of the plate via photograph received.Device was not returned and lot number was not provided, therefore device history review and complaint history review could not be performed.It is not possible identify a specific root cause as it is unknown how the screw was initially placed and/or the activity that the patient participated in following surgery.
Event or Problem Description
It was reported that the screw from initial procedure backed out.Surgeon performed revision procedure to remove the screw and replace with revision screw.

• Brand Name: FIXED ANGLE BONE SCREW DIAM 4.0 X 14MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7106249
• Report Number: 0009617544-2017-00432
• Device Sequence Number: 13778183
• Product Code: MNH
• UDI-Device Identifier: 04546540392954
• UDI-Public: (01)04546540392954
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48674014
• Device Catalogue Number: 48674014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 100