MAUDE Adverse Event Report: K2M, INC. SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X16 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 8801-04016DA

Device Problem Fracture (1260)

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

Event Date 04/01/2019

Event Type  Injury  

Event Description

A patient was revised to provide supplemental fixation following fracture of two ozark screws.One ozark screw at c7 was noted to have fractured approximately 6-months post-operatively; one ozark screw at c4 was noted to have fractured approximately 26-months post-operatively.The devices remain implanted.This report captures the fractured ozark screw at c4.

Manufacturer Narrative

H3 other text : device remains implanted.

Manufacturer Narrative

H6 coding has been updated to reflect completion of the investigation.

Event Description

A patient was revised to provide supplemental fixation following fracture of two ozark screws.One ozark screw at c7 was noted to have fractured approximately 6-months post-operatively; one ozark screw at c4 was noted to have fractured approximately 26-months post-operatively.The devices remain implanted.This report captures the fractured ozark screw at c4.

• Brand Name: SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X16 MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 17684702
• MDR Text Key: 322658744
• Report Number: 3004774118-2023-00109
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10888857393387
• UDI-Public: 10888857393387
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172104
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8801-04016DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/18/2024
• 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
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 121 KG