MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN REFLEX SCREW; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number UNK_SPN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2023

Event Type  Injury  

Event Description

The article 'the surgical outcome of multilevel anterior cervical discectomy and fusion in myelopathic elderly and younger patients' in scientific reports, volume 12 (4495) 2022, was reviewed.Consecutive patients with degenerative cervical myelopathy treating by primary multilevel acdf (3 or more levels) and plate fixation by a single surgeon from january 2006 to september 2019 were retrospectively reviewed.Postoperative events were recorded including nonunion, cage subsidence, implant loosening, pseudoarthrosis, surgical site infection, adjacent segment pathology, revision surgery as surgical related and pneumonia, sepsis, kidney failure, cerebrovascular accident, myocardial infarction as medical disease related.These complications were grouped into short-term as occurrence within 1 year and middle-term as occurrence more than 1 year.The surgical complications were further categorized as need to have reoperation or not.A total of 63 patients including 45 males and 18 females were studied.Multilevel acdf was performed at three level in 49 patients, four-level in 13 patients and five-level in 1 patient.Patients were implanted with the reflex hybrid plate system.This report captures one patient who experienced "deep surgical site infection" approximately one-year after index surgery.The patient underwent debridement and removal of implant.

Manufacturer Narrative

Device location unknown.

• Brand Name: UNKNOWN REFLEX SCREW
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 18017057
• MDR Text Key: 326675371
• Report Number: 0009617544-2023-00068
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• 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