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

Model Number	8801-04016DA
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neck Pain (2433); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that an unknown amount of ozark self-starting, variable screws fractured 4-6 months post-operatively.The patient is now experiencing neck pain.Revision surgery is not scheduled at this time.As eight screws were implanted during index surgery spanning c4, c5, c6, and c7, all eight screws will be reported conservatively.This record captures the sixth of eight screws.
Event or Problem Description
Following the visual inspection of received radiographic images, it was confirmed that only two screws fractured.The complaint screws are captured under reports 3004774118-2020-00173 and 3004774118-2020-00174.Therefore, this ozark self-starting variable screw is concomitant.
Additional Manufacturer Narrative
B5 was updated to reflect this device is concomitant.This device was deemed concomitant as radiographic images confirmed only two screws fractured.

• Brand Name: SELF-STARTING, 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: 10399320
• Report Number: 3004774118-2020-00178
• Device Sequence Number: 2880683
• Product Code: KWQ
• UDI-Device Identifier: 10888857393387
• UDI-Public: 10888857393387
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8801-04016DA
• Device Catalogue Number: 8801-04016DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other