MAUDE Adverse Event Report: STRYKER SPINE-US 7.5X80 MEDIAL BIASED ANGLE POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482677580

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 04/17/2021

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported that two xia serrato polyaxial screw tulips disengaged post-operatively.Revision surgery is not planned at this time.This report captures the first of the two screws.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Due to no product return, x-rays, and insufficient information regarding initial procedure, no root cause could be determined conclusively.Potential root causes include: excessive torque applied to blocker, improper alignment of rod in tulip head, external trauma, patient compliance issues, delayed healing, and more.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker.If devices and / or additional information become available, this investigation will be reopened.

Event Description

It was reported that two xia serrato polyaxial screw tulips disengaged post-operatively.Revision surgery is not planned at this time.This report captures the first of the two screws.

• Brand Name: 7.5X80 MEDIAL BIASED ANGLE 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-FRANCE; zone industrielle de marticot; -; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12576892
• MDR Text Key: 274755641
• Report Number: 3005525032-2021-00042
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327351699
• UDI-Public: 07613327351699
• 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: 01/19/2022

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
• Device Operator: Health Professional
• Device Model Number: 482677580
• Device Catalogue Number: 482677580
• Device Lot Number: B74702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2017
• 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