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

Model Number	4501-15048
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3004774118-2022-00217
• Device Sequence Number: 4390998
• Product Code: KWQ
• UDI-Device Identifier: 10888857093270
• UDI-Public: 10888857093270
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 96 KG