MAUDE Adverse Event Report: STRYKER SPINE-US 9.5X100 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 4826195100

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

Status and location of the device is unknown.

Event Description

It was reported that a xia 3 blocker migrated from a xia serrato polyaxial screw at s2 approximately 1 year post-operatively.It is not known at this time if revision surgery has been scheduled or performed.This report captures the screw.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history records were reviewed for this catalog number, no adverse trends were identified.Initial report states that the left s2 screw set screw popped out [migrated] post-op.No images, x-rays, or products were received.As it is the job of the set screw to hold the screw in place and there are no alleged deficiencies with the screw, this device did not contribute to the event.Report #3005525032-2022-00012 has been filed to capture the set screw.

Event Description

It was reported that a xia 3 blocker migrated from a xia serrato polyaxial screw at s2 approximately 1 year post-operatively.It is not known at this time if revision surgery has been scheduled or performed.This report captures the screw.

• Brand Name: 9.5X100 POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; SZ 2300
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14470886
• MDR Text Key: 300360127
• Report Number: 3005525032-2022-00013
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327351750
• UDI-Public: 07613327351750
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170496
• 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: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4826195100
• Device Catalogue Number: 4826195100
• Device Lot Number: B75438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2017
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 85 KG