MAUDE Adverse Event Report: K2M, INC. EXPANDABLE ALIF; SIZE 28X36X13 MM, 5°; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 5808-21336L5

Device Problems Mechanical Jam (2983); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2022

Event Type  malfunction  

Event Description

It was reported that a sahara al lumbar interbody spacer locking mechanism was found to be problematic outside the or.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.

Event Description

It was reported that a sahara al lumbar interbody spacer locking mechanism was found to be problematic outside the or.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.

Manufacturer Narrative

The returned device had severe wear, especially around the inserter attachment site.Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history was reviewed and no similar complaints for the reported catalogue number were identified.The sahara al surgical technique was reviewed and the following identified: ensure the interbody is partially locked, as shown below, making sure that there is no gap between the locking teeth and that the nut is positioned posteriorly.Insert the interbody into the disc space using the inserter/expander.After the interbody is properly seated into the disc space, the large mallet may be used to aid in implant placement.X-ray or fluoroscopy may be used live or periodically to verify placement.Insert the size 8 non-tapered driver (while attached to the black 6 in-lbs torque limiting handle) through the hole labeled 'lock' on proximal end of the inserter/expander and rotate clockwise to final tighten the set screw to 6 in-lbs.The torque limiting handle is designed emit an audible 'click' at 6 in-lbs to indicate that the interbody is locked.As the locking bands behind the locking teeth are bent further back than normal, it is likely that the device was over-expanded during prep which caused the locking mechanism to be deformed back so that it is unable to engage, resulting in the jam failure.

• Brand Name: EXPANDABLE ALIF; SIZE 28X36X13 MM, 5°
• Type of Device: 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: 14655924
• MDR Text Key: 295315970
• Report Number: 3004774118-2022-00230
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 10888857213234
• UDI-Public: 10888857213234
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5808-21336L5
• Device Catalogue Number: 5808-21336L5
• Device Lot Number: FAAJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1