MAUDE Adverse Event Report: STRYKER SPINE-US 9.5X60 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 482619560

Device Problems Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 04/11/2019

Event Type  Injury  

Event Description

It was reported that the screw went "inward too much" and neurological symptoms appeared, resulting in revision surgery.

Event Description

It was reported that the screw went "inward too much" and neurological symptoms appeared, resulting in revision surgery.

Manufacturer Narrative

Correction: hospital declined to return the device for evaluation.Visual, dimensional, functional inspection, and material analysis could not be performed as the device was not returned.Complaint history records were not reviewed as a valid lot number was not provided and could not be obtained.Manufacturing history records were not reviewed as a valid lot number was not provided and could not be obtained.The device was implanted concomitantly with a non-stryker rod and offset connector.It is unknown the angle of the screw, how the screw holes were prepped, and what instrument was used to insert the screw.No x -rays or notes were provided.Based on information provided, there is not enough information to determine why the screw migrated inward.From the ifu: "because different manufacturers employ different materials, varying tolerances and manufacturing specifications, and differing design parameters, components of the system should not be used in conjunction with components from any other manufacturer¿s spinal system.Any such use will negate the responsibility of stryker spine for the performance of the resulting mixed component implant.".

• Brand Name: 9.5X60 POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8561769
• MDR Text Key: 143450905
• Report Number: 3005525032-2019-00034
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327352320
• UDI-Public: 07613327352320
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 482619560
• Device Lot Number: B83440
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/29/2019
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention