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

Model Number	482619590
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device discarded by hospital.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10261164
• Report Number: 3005525032-2020-00031
• Device Sequence Number: 3484618
• Product Code: NKB
• UDI-Device Identifier: 07613327351576
• UDI-Public: 07613327351576
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: Health Professional
• Device Model Number: 482619590
• Device Catalogue Number: 482619590
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 09/24/2020
• 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: Other