MAUDE Adverse Event Report: STRYKER SPINE-US 8.5X70 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482618570

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

Doctor has kept the device.

Event Description

It was reported that the tulip of a xia serrato polyaxial screw located at s5 "came apart" from the shaft post-operatively.Revision surgery has been performed where the screw was explanted.

Event Description

It was reported that the tulip of a xia serrato polyaxial screw located at s5 "came apart" from the shaft post-operatively.Revision surgery has been performed where the screw was explanted.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Photos were provided showing the tulip disengaged from the shank.Photos were not clear enough to make out any deformation or witness marks on the screw.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 device was not returned and no further information was provided, a cause cannot be determined.According to the ifu, possible causes include patient activity level, patient fall, patient weight, and/or improper implantation.

• Brand Name: 8.5X70 POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10693098
• MDR Text Key: 211844812
• Report Number: 3005525032-2020-00041
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327351736
• UDI-Public: 07613327351736
• Combination Product (y/n): N
• PMA/PMN Number: K170496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482618570
• Device Catalogue Number: 482618570
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention