MAUDE Adverse Event Report: K2M. INC ALEUTIAN ® INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT

Catalog Number 602-90780

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problem No Information (3190)

Event Date 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation but evaluation is still in progress.Upon completion of evaluation of the subject part, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a surgery took place in which oblique inserters did not function as intended intra-operatively, as a result the surgeon reported that during the insertion and removal of cages, there might be some possible damage to the right nerve root.(related to 3004774118-2018-00185).

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.Upon review of the inner shaft, it was observed that the proximal head had sheared from the instrument.The shear face was coarse and raised, which is suggestive of brittle fracture sustained during impaction while inserting the second implant.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a surgery took place in which oblique inserters did not function as intended intra-operatively, as a result, the surgeon reported that during the insertion and removal of cages there might be some possible damage to the right nerve root (related to 3004774118-2018-00185).

• Brand Name: ALEUTIAN ® INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va 20175
• MDR Report Key: 8162508
• MDR Text Key: 130338882
• Report Number: 3004774118-2018-00186
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K160547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 602-90780
• Device Lot Number: FXMV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Date Manufacturer Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6101-21033206NT LOT GXEE-34386; 6101-90167 LOT EPRX, FWCJ; 6101-90167 LOT EPRX, FWCJ
• Patient Weight: 75