MAUDE Adverse Event Report: K2M, INC. SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X14 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-04014DA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported that two ozark screws at c6 fractured approximately 4 months post-operatively.Revision surgery has not been performed or scheduled at this time.This report captures the second screw.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device remains implanted in the patient.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, similar complaints were identified.Follow-up communication was conducted with the sales rep, surgeon, and internal healthcare professional (hcp).The representative reported that there were no adverse events with the patient and no noticeable subsidence of the grafts.The screws appear to be within the angles in the stg.Internal hcp confirms that there is no evidence of cage subsidence.However, it was noted that the cages are not recessed completely into the disc space and that the upper cage appears to be contacting the plate.The plate is not completely approximated to the bone at the upper and lower levels, there is a gap between them.The ozark view and guide surgical technique was reviewed and the following relevant information was identified: 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.Loads produced by load bearing and activity levels will impact the longevity of the implant.Implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant re-mains implanted after complete healing, it can actually increase the risk of refracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Due to the devices remaining implanted and not available for inspection, a definitive root cause could not be determined.Potential causes of fracture include, but are not limited to: patient anatomical factors, patient non-compliance, patient accident/trauma, and/or normal mechanical limitations of the implant(s).The plate potentially resting on the cage may have contributed to the event, but could not be confirmed without devices being returned.
Event or Problem Description
It was reported that two ozark screws at c6 fractured approximately 4 months post-operatively.Revision surgery has not been performed or scheduled at this time.This report captures the second screw.

• Brand Name: SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X14 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: 14691334
• Report Number: 3004774118-2022-00233
• Device Sequence Number: 15148100
• Product Code: KWQ
• UDI-Device Identifier: 10888857393363
• UDI-Public: 10888857393363
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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: 8801-04014DA
• Device Catalogue Number: 8801-04014DA
• 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: 05/16/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 09/07/2022
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 91 KG