MAUDE Adverse Event Report: K2M, INC. SELF-STARTING, VARIABLE SCREW; SIZE 4.0X14 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	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that an ozark variable screw fractured at c7 approximately 6 months post-operatively.Fusion was not achieved.Revision surgery has not been scheduled or performed at this time.
Additional Manufacturer Narrative
D6b: date of implant and explant corrected.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.  device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.After review of x-ray and correspondence with rep, the most likely root cause was determined to be delayed healing, patient did not fuse.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.Another possible root cause may be not using the drill guides.Drill guides help prevent over angulation of screw placement, which helps prevent excessive stress applied to construct.H3 other text : status and location of the device is unknown.
Event or Problem Description
It was reported that an ozark variable screw fractured at c7 approximately 6 months post-operatively.Fusion was not achieved.Revision surgery has not been scheduled or performed at this time.

• Brand Name: SELF-STARTING, VARIABLE SCREW; SIZE 4.0X14 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11219583
• Report Number: 3004774118-2021-00018
• Device Sequence Number: 3446284
• Product Code: KWQ
• UDI-Device Identifier: 10888857393363
• UDI-Public: 10888857393363
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 8801-04014DA
• Device Catalogue Number: 8801-04014DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1