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	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician reported a fractured ozark screw at c4 approximately seven months after implant.Revision surgery has not been scheduled.
Event or Problem Description
A physician reported a fractured ozark screw at c4 approximately seven months after implant.Revision surgery has not been scheduled.
Additional Manufacturer Narrative
Inspection of the device was not possible as it remains implanted in the patient.A review of device history records could be not performed as the subject lot number was provided.A review of complaint history for this catalogue number identified no adverse trends.The patient was implanted with hardware on (b)(6) 2019.The construct was composed of a three (3) level plate, eight (8) screws, and bone graft.Upon review of the provided radiographic image, the reported fracture was confirmed.The construct spanned from c4 to c7.The fracture appears to have occurred at the superior-most level of the construct (c4).It was communicated that the implanted bone graft (non-stryker product) at c4/c5 had fractured, and 2-3 mm of plate subsidence was observed.The patient has been on testosterone for 5 years and it is possible that the patient had poor bone density.Evidence of fusion cannot be confirmed in the provided image.It is likely that the cause of the observed issue was multifactorial.The fracture of the bone graft and subsidence in the superior level may have created unanticipated loading at c4.Lack of arthrodesis in those levels could have contributed to the observed fracture as well.According to the ozark surgical technique, if healing is delayed or does not occur, the implant could break, bend, or loosen.

• 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: 11398368
• Report Number: 3004774118-2021-00063
• Device Sequence Number: 3381861
• Product Code: KWQ
• UDI-Device Identifier: 10888857393363
• UDI-Public: 10888857393363
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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: 02/02/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1