MAUDE Adverse Event Report: K2M, INC. SCREW, SELF-TAPPING; SIZE Ø3.5X14 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	6801-13514C
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during screw insertion, a pyrenees self tapping screw fractured at c7.The shaft of the screw was left in the patient.The procedure was completed successfully with a five minute surgical delay.There were no adverse consequences to the patient.
Event or Problem Description
It was reported that during screw insertion, a pyrenees self tapping screw fractured at c7.The shaft of the screw was left in the patient.The procedure was completed successfully with a five minute surgical delay.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
The returned component was visually inspected, and it was observed that the proximal head of the screw fractured from the shaft.Complaint history was reviewed for the corresponding lot and catalog number, and no adverse trends were identified.It was communicated from the field that the screw was locked successfully into the plate.It is possible that proximal head of the screw fractured due to insufficient bone prep, insertion into hard bone, difficult angulation during insertion, etc.However, from the available information, the cause of the event could not be established conclusively.

• Brand Name: SCREW, SELF-TAPPING; SIZE Ø3.5X14 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: 12239876
• Report Number: 3004774118-2021-00226
• Device Sequence Number: 4137124
• Product Code: KWQ
• UDI-Device Identifier: 10888857261396
• UDI-Public: 10888857261396
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K153526
• 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): 11/16/2021

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: 6801-13514C
• Device Catalogue Number: 6801-13514C
• Device Lot Number: PCMH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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