MAUDE Adverse Event Report: K2M, INC. SCREW, SELF STARTING; SIZE Ø5.0X40 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	4501-15040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A user reported that a cayman mi self-starting screw fractured during implantation.The surgeon left the screw in place and surgery was completed with no adverse consequences to the patient and no reported surgical delay.
Additional Manufacturer Narrative
This event was previously reported to the fda by the user; uf/importer report # (b)(4).Device remains implanted.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A user reported that a cayman mi self-starting screw fractured during implantation.The surgeon left the screw in place and surgery was completed with no adverse consequences to the patient and no reported surgical delay.

• Brand Name: SCREW, SELF STARTING; SIZE Ø5.0X40 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: 15417949
• Report Number: 3004774118-2022-00336
• Device Sequence Number: 16840573
• Product Code: KWQ
• UDI-Device Identifier: 10888857093119
• UDI-Public: 10888857093119
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K131533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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: 4501-15040
• Device Catalogue Number: 4501-15040
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 12/07/2022
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 110 KG