MAUDE Adverse Event Report: K2M, INC. CONVEX TRIAL; SIZE 10X32X11 MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	602-90367
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the laser markings of the aleutian an convex trial were observed to be worn intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.
Additional Manufacturer Narrative
A visual inspection was performed and the laser marking on the trial is wearing off as reported.No other visual anomalies were identified.Device history records were reviewed for the corresponding lot and no relevant issues were identified.The trial has been in use for approximately 10.5 years.Complaint history record review was performed for this lot, and no similar complaints were identified.It was reported that the laser marking on the trial is wearing off and the trial needs to be replaced.There was no other issue with the trial intra-operatively.No patient harm and no surgical delay resulted from this event.The cause of the reported event is normal wear and tear due to device age, usage, cleaning and sterilization cycles.
Event or Problem Description
It was reported that the laser markings of the aleutian an convex trial were observed to be worn intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.

• Brand Name: CONVEX TRIAL; SIZE 10X32X11 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: 13022254
• Report Number: 3004774118-2021-00402
• Device Sequence Number: 4948756
• Product Code: MAX
• UDI-Device Identifier: 10888857116757
• UDI-Public: 10888857116757
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K150481
• 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): 03/24/2022

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: 602-90367
• Device Catalogue Number: 602-90367
• Device Lot Number: APTU
• 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: 11/19/2021
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown