MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

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

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

Status and location of the device is unknown.

Event Description

It was reported that approximately 1 month post-operatively, the patient fell from a standing position resulting in the migration of a cage and two xia serrato screws.The patient was revised.This report captures the second of the two screws.

Event Description

It was reported that approximately 1 month post-operatively, the patient fell from a standing position resulting in the migration of a cage and two xia serrato screws.The patient was revised.This report captures the second of the two screws.

Manufacturer Narrative

Field b1 has been corrected from 'adverse event product problem' to 'adverse event'.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records could not be reviewed as a valid lot or catalog number was not provided and could not be obtained.Initial report states that the patient fell from standing approximately a month out from surgery.The l5 inferior screws broke out of the pedicle inferiority and the prolift cage retropulsed posteriorly, lateral to the spinal canal.The patient was revised.It was also reported that the patient had average bone quality.No nerve or soft tissue damage was noted.X-rays pre and post-event were reviewed.Post-event x-ray confirms the cage migrated posteriorly.Screw break out of pedicles could not be confirmed via x-ray as no significant change in position was noted.However, no ap x-ray was provided and it was reported that the screw did break out of the pedicle.No mechanical failure mode was identified for the screws themselves.Device stg reviewed: postoperative care.Prior to adequate maturation of the fusion mass, implanted spinal instrumentation may need additional help to accommodate full load bearing.External support may be recommended by the physician from two to four months postoperatively or until x-rays or other procedures confirm adequate maturation of the fusion mass; external immobilization by bracing or casting may be employed.Surgeons must instruct patients regarding appropriate and restricted activities during consolidation and maturation for the fusion mass in order to prevent placing excessive stress on the implants which may lead to fixation or implant failure and accompanying clinical problems.Surgeons must instruct patients to report any unusual changes of the operative site to his/her physician.The physician should closely monitor the patient if a change at the site has been detected.The most likely cause of the reported event was determined to be due to the patient fall experienced 1 month post-op.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• 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: 14743883
• MDR Text Key: 294881811
• Report Number: 0009617544-2022-00067
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male