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

Model Number 482619590

Device Problem Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

Device discarded by hospital.

Event Description

It was reported that while final tightening two xia serrato polyaxial screws at s2ai, the tulips separated from the shafts.One of the screw shafts was removed entirely and one of the screw shafts remained in the patient¿s bone.The procedure was completed with a surgical delay of three-hours and the construct was completed with the use of iliac bolts.This record represents the screw which was fully removed from the patient.

Event Description

It was reported that while final tightening two xia serrato polyaxial screws at s2ai, the tulips separated from the shafts.One of the screw shafts was removed entirely and one of the screw shafts remained in the patient¿s bone.The procedure was completed with a surgical delay of three-hours and the construct was completed with the use of iliac bolts.This record represents the screw which was fully removed from the patient.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, a photo was provided showing a disengaged tulip head.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.As the screw was not returned, a definite root cause cannot be determined.Overangulation can cause the screw tulip to disengage.Additionally, the possibility of hubbing of the screw into bone eliminates the ability of the tulip to maintain polyaxiality which is important to ensure the rod can properly seat in tulip rod slot.Loss of polyaxiality does make it more difficult to seat the rod into the tulip and would hinder good seating of the rod in the tulip.Improper seating of the rod can cause additional force to be applied to the tulip during final tightening, which may lead to disengagement.

• Brand Name: 9.5X90 POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10261164
• MDR Text Key: 198501734
• Report Number: 3005525032-2020-00031
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327351576
• UDI-Public: 07613327351576
• Combination Product (y/n): N
• PMA/PMN Number: K170496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482619590
• Device Catalogue Number: 482619590
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other