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

Model Number	201-14016C
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in the patient.
Event or Problem Description
It was reported that two pyrenees self-tapping screws fractured post-operatively at c6.Revision surgery has not been scheduled nor performed at this time.This record captures the second of the two reported pyrenees screws.
Event or Problem Description
It was reported that two pyrenees self-tapping screws fractured post-operatively at c6.Revision surgery has not been scheduled nor performed at this time.This record captures the second of the two reported pyrenees screws.
Additional Manufacturer Narrative
As the fractured screws remain implanted in the patient, an evaluation could not be performed.Upon review of the provided radiographic image, it was observed that the construct was composed of a 3 level plate, 8 screws, and interbody spacers.Correspondence with the field representative suggests there were no complications during the initial surgery.The screws were final tightened until the torque handle click was heard, and the screws were not repositioned after first insertion.A drill was used to prepare screw holes; the bone was not tapped.The surgery was not performed at a difficult angle, and a drill guide was not used.The patient did not experience external trauma and had normal activity levels.Operative notes were not available.Device and complaint history records could not be reviewed as the device lot number was not available.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.From the pyrenees surgical technique guide, "the fixed screw- thru drill guide can be used to tap, drill and insert screws at a trajectory of 12 degrees and, along with the variable screw-thru drill guide, provides a positive docking onto the plate.The variable screw-thru drill guide provides the surgeon with 30 degrees conical range of motion to tap, drill, and insert screws." (page 15) it is possible that an adequate angulation was not provided that may have led to the fracture of screws.However, as the devices remain implanted in the patient, further evaluation was not possible, and a cause could not be established conclusively.

• Brand Name: SELF-TAPPING SCREW, CONSTRAINED; SIZE Ø4.0X16 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: 12564103
• Report Number: 3004774118-2021-00297
• Device Sequence Number: 1336807
• Product Code: KWQ
• UDI-Device Identifier: 10888857027022
• UDI-Public: 10888857027022
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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: 201-14016C
• Device Catalogue Number: 201-14016C
• 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: 09/03/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 01/18/2022
• 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: Unknown