MAUDE Adverse Event Report: K2M, INC. SELF-TAPPING, VARIABLE SCREW; SIZE 4.0X16 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-04016CA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
A physician reported that an ozark view self-tapping screw in c6 was observed to be fractured in a post-operative x-ray approximately four to six-months after implantation.It is unknown at this time if revision surgery will take place.
Event or Problem Description
A physician reported that an ozark view self-tapping screw in c6 was observed to be fractured in a post-operative x-ray approximately four to six-months after implantation.Revision surgery has not been scheduled.
Additional Manufacturer Narrative
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.It was reported that an ozark view self-tapping variable screw had fractured postoperatively.However, screw fracture could not be confirmed since the device was not returned and no images of the construct were available for evaluation.It is not clear what may have caused the screw to fracture, although it is possible that factors such as pseudoarthrosis contributed to the issue.Ultimately, no root cause could be determined based on the available information.

• Brand Name: SELF-TAPPING, VARIABLE SCREW; SIZE 4.0X16 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10488805
• Report Number: 3004774118-2020-00194
• Device Sequence Number: 2925601
• Product Code: KWQ
• UDI-Device Identifier: 10888857392878
• UDI-Public: 10888857392878
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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: 8801-04016CA
• Device Catalogue Number: 8801-04016CA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 10/31/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1