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

Model Number 482619590

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2017

Event Type  malfunction  

Event Description

It was reported that the poly head popped off of the screw.

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 Description

It was reported that the poly head popped off of the screw.

• Brand Name: 9.5X90 POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7079544
• MDR Text Key: 93872974
• Report Number: 3005525032-2017-00109
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 07613327351576
• UDI-Public: (01)07613327351576
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 02/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1