MAUDE Adverse Event Report: K2M, INC. AN INTERBODY; SIZE 8.5X28X10 MM, 12°; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6101-2852810NL12-G2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that a cascadia an lordotic interbody was observed to be fractured post-operatively.Revision surgery has not been scheduled at this time.
Event or Problem Description
It was reported that a cascadia an lordotic interbody fractured during insertion.The device remains implanted.Revision surgery has not been scheduled at this time.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device remains implanted.A review of the device history records could not be performed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog, and no similar complaints were identified.Without the device and lack of information, an exact cause of the event cannot be determined.Failure of this nature can occur if the implant is too large for the disc space or if the patient's disc space is too tight, leading to device fracture during rotation due to a lack of clearance and high resistance.

• Brand Name: AN INTERBODY; SIZE 8.5X28X10 MM, 12°
• 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: 12941401
• Report Number: 3004774118-2021-00379
• Device Sequence Number: 20035228
• Product Code: MAX
• UDI-Device Identifier: 10888857316379
• UDI-Public: 10888857316379
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K172009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: 6101-2852810NL12-G2
• Device Catalogue Number: 6101-2852810NL12-G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 03/30/2022
• 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 Sex: Unknown