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

Model Number 8801-04016DA-G1

Device Problem Fracture (1260)

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

Event Date 04/21/2022

Event Type  malfunction  

Event Description

It was reported that two ozark screws fractured at c7 approximately 2 months post-operatively.Revision surgery has not been performed nor scheduled at this time.This report captures the second screw.

Manufacturer Narrative

Devices remains implanted.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device remains implanted in the patient.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were identified.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established with the information available.If additional information is received, the investigation will be reopened and updated.

Event Description

It was reported that two ozark screws fractured at c7 approximately 2 months post-operatively.Revision surgery has not been performed nor scheduled at this time.This report captures the second screw.

• 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: 14428297
• MDR Text Key: 291942297
• Report Number: 3004774118-2022-00196
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10888857408869
• UDI-Public: 10888857408869
• 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: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8801-04016DA-G1
• Device Catalogue Number: 8801-04016DA-G1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2022
• 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 Age: 74 YR
• Patient Weight: 91 KG