MAUDE Adverse Event Report: K2M, INC. IMPLANT; SIZE 24X30X15 MM, 10°; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	2013-21530L10
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a chesapeake lumber case, the universal awl 'skived' off the endplate and did not create the necessary pilot hole for the screw.This resulted in the cages at s1 and l4 having only 2 screws inserted instead of 3.Additionally, during screw insertion, the angled tapered driver came off of the screw.It was also observed that the laser markings had worn off of the expandable drill guide.This report will capture the first of two cages.
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that during a chesapeake lumber case, the universal awl 'skived' off the endplate and did not create the necessary pilot hole for the screw.This resulted in the cages at s1 and l4 having only 2 screws inserted instead of 3.Additionally, during screw insertion, the angled tapered driver came off of the screw.It was also observed that the laser markings had worn off of the expandable drill guide.This report will capture the first of two cages.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were observed.Additional information indicates the surgeon is familiar with the chesapeake system and, "they do not always put in three screws." based on the available information, the implant was placed with only two screws as a result of surgeon preference and difficulty with assembly.".

• Brand Name: IMPLANT; SIZE 24X30X15 MM, 10°
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, 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: 13655343
• Report Number: 3004774118-2022-00080
• Device Sequence Number: 5749733
• Product Code: OVD
• UDI-Device Identifier: 10888857027862
• UDI-Public: 10888857027862
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K142487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: 2013-21530L10
• Device Catalogue Number: 2013-21530L10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 60 YR
• Patient Sex: Female