MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number UNK_SPE

Device Problems Biocompatibility (2886); Migration (4003)

Patient Problems Post Operative Wound Infection (2446); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  Injury  

Event Description

A patient underwent revision surgery one year after implantation to address two migrated tasman set screws.It was further reported that within the last year the patient has undergone several "wound wash outs" for infection and has been on a long course of antibiotics.This report captures the second of two tasman set screws.

Event Description

A patient underwent revision surgery one year after implantation to address two set screw migrations.One device has been confirmed to be an everest set screw but the second device remains unspecified.It was further reported that within the last year the patient has undergone several "wound wash-outs" for infection and has been on a long course of antibiotics.This report captures the unspecified set screw.

Manufacturer Narrative

H3 other text : no product returned.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• 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: 17233452
• MDR Text Key: 318173057
• Report Number: 3004774118-2023-00087
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: No
• 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