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

Model Number	4826195100
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005525032-2022-00013
• Device Sequence Number: 4722706
• Product Code: NKB
• UDI-Device Identifier: 07613327351750
• UDI-Public: 07613327351750
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 85 KG