MAUDE Adverse Event Report: K2M, INC. SCREW, SELF STARTING; SIZE Ø5.0X48 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 4501-15048

Device Problem Fracture (1260)

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

Event Date 05/09/2022

Event Type  malfunction  

Event Description

It was discovered via x-ray that a cayman self starting screw fractured at the neck after successful insertion.The screw was left in the patient.Revision surgery has not been scheduled or performed at this time.

Manufacturer Narrative

Device remains implanted.

Event Description

It was discovered via x-ray that a cayman self starting screw fractured at the neck after successful insertion.The screw was left in the patient.Revision surgery has not been scheduled or performed at this time.

Manufacturer Narrative

Visual, dimensional, functional and material analysis could not be performed as the device remains implanted in the patient.However, an x-ray provided shows the screw is in place, the fracture is not visible.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 identiifed.The head fracture is likely due to the plate being uneven during screw insertion which would cause additional force on the plate which then would translate to localize force on the screw head.However the root cause could not be confirmed as limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.If additional information is received, the investigation will be reopened and updated.

• Brand Name: SCREW, SELF STARTING; SIZE Ø5.0X48 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: 14622109
• MDR Text Key: 293555280
• Report Number: 3004774118-2022-00217
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10888857093270
• UDI-Public: 10888857093270
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131533
• 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: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4501-15048
• Device Catalogue Number: 4501-15048
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2022
• 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 Sex: Male
• Patient Weight: 96 KG