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

Catalog Number UNK_SPN

Device Problems Device Slipped (1584); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); No Information (3190); No Code Available (3191)

Event Date 03/12/2019

Event Type  Injury  

Event Description

It was reported that the screw was loosened post-operatively.The patient underwent revision surgery for screw replacement and construct extension.

Event Description

It was reported that the screw was loosened post-operatively.The patient underwent revision surgery for screw replacement and construct extension.

Manufacturer Narrative

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.It was reported that the screw loosening occurred due to patient factors; surgeon made an attempt to perform revision surgery on (b)(6) 2019 to explant the loosened screw and extend l2/s2; however, due to patient factors, the surgery was discontinued and revision surgery was later performed on (b)(6) 2019.Root cause of the reported event was determined to be patient factors.The patient was on hemodialysis and suffered ruptured spondylarthrosis.Per the surgical technique: "loosening of spinal fixation implants can occur.Early mechanical loosening may result from inadequate initial fixation, latent infection, premature loading of the prosthesis or trauma.Late loosening may result from trauma, infection, biological complications or mechanical problems, with the subsequent possibility of bone erosion, migration and/or pain." device remains implanted in patient.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8507283
• MDR Text Key: 141723585
• Report Number: 0009617544-2019-00046
• Device Sequence Number: 0
• Product Code: NKB
• PMA/PMN Number: K122845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2019
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 58