MAUDE Adverse Event Report: K2M. INC CASCADIA¿ INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT LUMBAR

Catalog Number 6101-90167

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 two oblique inserters did not function as intended intra-operatively.As a result the surgeon reported that during all the insertion and removal of cages, there might be some possible damage to the right nerve root.(related to 3004774118-2018-00186).

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.Upon review of one of the cascadia an lordotic-oblique inserters, it was observed that the distal tip was sheared from the instrument.The shear face was coarse and raised, which is suggestive of brittle fracture sustained during rotation of the implant in-situ.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a surgery took place in which two oblique inserters did not function as intended intra-operatively.As a result the surgeon reported that during all insertion and removal of cages, there might be some possible damage to the right nerve.( related to 3004774118-00186).

• Brand Name: CASCADIA¿ INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT LUMBAR
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va 20175
• MDR Report Key: 8162472
• MDR Text Key: 130332303
• Report Number: 3004774118-2018-00185
• 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: 6101-90167
• Device Lot Number: EPRX,FWCJ
• 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: 602-90780 LOT FXMV; 602-90780 LOT FXMV; 6110-2103206NT 12-G2 LOT GXEE-34386
• Patient Weight: 75