MAUDE Adverse Event Report: K2M, INC. CONVEX IMPLANT; SIZE 8.5X22X8 MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	603-20822C
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part of the fractured device was left in the patient but the rest of device is to be returned.
Event or Problem Description
It was reported that during rotation an aleutian an interbody fractured and part of the fractured implant was left in the patient.The surgery was completed successfully with an unknown surgical delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that during rotation an aleutian an interbody fractured and part of the fractured implant was left in the patient.The surgery was completed successfully with an unknown surgical delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.

• Brand Name: CONVEX IMPLANT; SIZE 8.5X22X8 MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 15324772
• Report Number: 3004774118-2022-00332
• Device Sequence Number: 20213255
• Product Code: MAX
• UDI-Device Identifier: 10888857121867
• UDI-Public: 10888857121867
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K110843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: 603-20822C
• Device Catalogue Number: 603-20822C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Female
• Patient Weight: 73 KG