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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
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 at c7 post-operatively.The event was noticed during a three month follow-up.There are no plans for revision surgery thus far.This record captures the first of the two reported pyrenees self-tapping screws.
Event or Problem Description
It was reported that two pyrenees self-tapping screws fractured at c7 post-operatively.The event was noticed during a three month follow-up.There are no plans for revision surgery thus far.This record captures the first of the two reported pyrenees self-tapping screws.
Additional Manufacturer Narrative
Upon review of the provided radiographic image, it was observed that the construct was composed of a two (2) level plate, six (6) screws, and interbody spacers.Bilateral screw migration was confirmed at the caudal most level of the construct.Complaint history was reviewed for the corresponding catalog number, and no adverse trends were observed.Correspondence with rep states that there were no issues during initial surgery.The fixed drill guide was used, and the screws were final tightened using the grey torque handle in the pyrenees set.The patient had normal activity levels and did not experience external trauma.The fixed drill guide provides a fixed angulation of 12 degrees.Review of x-ray image with a health care practitioner suggests that the indicated angulation of screws may not have been met, which may have contributed to the fracture as the pyrenees screws and construct are fixed.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.However, as the devices remain implanted in the patient and additional x-rays were not available, further evaluation was not possible, and the 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: 12515569
• Report Number: 3004774118-2021-00287
• Device Sequence Number: 5146549
• 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): 01/07/2022

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: 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): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 12/12/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 01/07/2022
• 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 Sex: Unknown