MAUDE Adverse Event Report: K2M, INC. EXPANDABLE ALIF; SIZE 28X36X12 MM, 5; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	5808-21236L5
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Remains implanted.
Event or Problem Description
It was reported that a couple days after the initial surgery, a sahara cage appears to have slightly collapsed.The surgeon stated that they are not sure if the cage did lose height.The patient is reported as doing fine and has not encountered any problems.As it is not clear if the device did in fact lose height, this event will be conservatively reported.
Event or Problem Description
It was reported that a couple days after the initial surgery, a sahara cage appears to have slightly collapsed.The surgeon stated that they are not sure if the cage did lose height.The patient is reported as doing fine and has not encountered any problems.As it is not clear if the device did in fact lose height, this event will be conservatively reported.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.We were unable to physically inspect the part, but radiological images were provided by the rep.Upon review of the images taken on (b)(6) 2021 and (b)(6) 2021, it was observed that the anterior portion of the implant had a small gap.Without being able to physically inspect the part and take measurements, we were unable to determine if the implant was at position 1 or position 2.Upon review of the image taken on (b)(6) 2021, there is no visible gap.However, due to the clarity of the ct, we were unable to confirm the implant's exact position.We were unable to determine if the sahara cage had collapsed.Without being able to physically inspect the part and take measurements, the exact position of the cage is unknown.Since the device is still implanted, a conclusive cause for the failure mode could not be identified.

• Brand Name: EXPANDABLE ALIF; SIZE 28X36X12 MM, 5
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11645316
• Report Number: 3004774118-2021-00103
• Device Sequence Number: 2999497
• Product Code: OVD
• UDI-Device Identifier: 10888857213203
• UDI-Public: 10888857213203
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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: 5808-21236L5
• Device Catalogue Number: 5808-21236L5
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 80