MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND 9.5X90 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482619590
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the poly head popped off of the screw.
Additional Manufacturer Narrative
The deformation on the locking ring and the screw shank was on one side of the implant, which suggests that the tulip head was pushed at an angle before deforming, as the tulip head disengaged.Applying cantilever or off axis loading to the implant can cause this deformation.Additionally, the rod being too proud while under persuasion can cause excess stress on the tulip head, however, this cannot be conclusively confirmed without x rays or photos of the event.Other factors such as rod position, incorrect alignment, and force applied can also contribute to the event.Due to the multifactorial nature of the event, an exact root cause cannot be determined.
Event or Problem Description
It was reported that the poly head popped off of the screw.

• Brand Name: 9.5X90 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 7079544
• Report Number: 3005525032-2017-00109
• Device Sequence Number: 11212129
• Product Code: MNH
• UDI-Device Identifier: 07613327351576
• UDI-Public: (01)07613327351576
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: 482619590
• Device Catalogue Number: 482619590
• Device Lot Number: B73959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 02/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1