MAUDE Adverse Event Report: K2M, INC. FIXED SCREW, SELF-STARTING; SIZE Ø4.35X18 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-14318DA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an ozark fixed screw at c4 fractured post-operatively.Revision surgery will not be performed.
Additional Manufacturer Narrative
Device remains implanted in patient.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the screw associated with this record was not returned.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 similar complaints were identified.Initial report states an ozark screw failed at c4, the top level of a corpectomy construct.It was reported that the patient will not be revised and that only one screw fractured.No trauma was experienced by the patient.No additional patient information was available.X-ray provided confirms that one cranial screw fractured.The x-ray provided was taken after event occurred.No post-op/pre-event x-ray was available to review.Cranial end of plate is not contacting the anterior surface of the vertebral body in the post-event x-ray.It cannot be confirmed if the plate was touching vertebral body after initial procedure.Ozark view and guide surgical technique was reviewed: ¿the plate should sit flush on the vertebral body.Excessive forces may be experienced by the screws if the plate is not in contact with the vertebral body¿.¿these internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur, the implant could eventually break, bend, or loosen.Physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices in the absence of complete bone healing.¿ due to lack of product information and device not returned, an exact cause of the reported event of the screw fracture cannot be conclusively determined at this time.
Event or Problem Description
It was reported that an ozark fixed screw at c4 fractured post-operatively.Revision surgery will not be performed.

• Brand Name: FIXED SCREW, SELF-STARTING; SIZE Ø4.35X18 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: 13712783
• Report Number: 3004774118-2022-00094
• Device Sequence Number: 17761522
• Product Code: KWQ
• UDI-Device Identifier: 10888857392557
• UDI-Public: 10888857392557
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• 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): 04/19/2022

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: 8801-14318DA
• Device Catalogue Number: 8801-14318DA
• 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: 09/07/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/19/2022
• 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