MAUDE Adverse Event Report: K2M, INC. ANGLED LATERAL INSERTER; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	7902-90102
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a cascadia lateral inserter broke off outside the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot and catalog number, no relevant manufacturing issues or adverse trends were identified.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established with the information available.If additional information is received, the investigation will be reopened and updated.H3 other text : status and location of the device is unknown.
Event or Problem Description
It was reported that the tip of a cascadia lateral inserter broke off outside the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• Brand Name: ANGLED LATERAL INSERTER
• 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: 14794710
• Report Number: 3004774118-2022-00252
• Device Sequence Number: 5876672
• Product Code: OVD
• UDI-Device Identifier: 10888857431478
• UDI-Public: 10888857431478
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172941
• 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): 09/12/2022

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: 7902-90102
• Device Catalogue Number: 7902-90102
• Device Lot Number: KNGF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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