MAUDE Adverse Event Report: K2M, INC. AN INSERTER INNER SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	602-90780
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an aleutian tlif ii straight inserter inner shaft was jammed intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with an unspecified surgical delay.
Event or Problem Description
It was reported that an aleutian tlif ii straight inserter inner shaft was jammed intra-operatively.The instrument would not function as intended due to a knob fracture.There were no adverse consequences to the patient.The procedure was completed successfully with an unspecified surgical delay.
Additional Manufacturer Narrative
B.5 was updated to reflect additional information received upon product return.
Event or Problem Description
Upon product return, the device was determined to be a fractured aleutian an inserter inner knob, not an aleutian tlif ii straight inserter inner shaft jam as previously reported.
Additional Manufacturer Narrative
Upon product return, the device was determined to be a fractured aleutian an inserter inner knob, not an aleutian tlif ii straight inserter inner shaft jam as previously reported.There have not been reports of death or serious injury resulting from similar events with this device.The reported information regarding this event do not suggest a recurrence of this event would result in a serious injury.Therefore, no further reporting is required.

• Brand Name: AN INSERTER INNER SHAFT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10213655
• Report Number: 3004774118-2020-00133
• Device Sequence Number: 16671100
• Product Code: MAX
• UDI-Device Identifier: 10888857157255
• UDI-Public: 10888857157255
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K160547
• 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,Followup
• Report Date (Section B): 10/02/2020

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: 602-90780
• Device Catalogue Number: 602-90780
• Device Lot Number: EHJX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 08/11/2020; 09/04/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 09/04/2020; 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1