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

Model Number 7012-90096

Device Problems Fracture (1260); Difficult to Insert (1316)

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

Event Date 03/11/2022

Event Type  malfunction  

Manufacturer Narrative

Hospital discarded.

Event Description

It was reported that a mojave inner shaft broke intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device associated with this record was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were identified.It was reported that a mojave inner shaft broke intra-operatively during cage expansion.The surgery was being performed at l4-s1.The device was not used at a difficult angle and the surgeon did not appear to apply excessive force when the issue occurred.The device has been used 2.5 years multiple times.Since the device was not returned, an exact cause of the reported event could not be determined.Potential causes include: normal wear due to device age/ extensive use, application of excess force during use, tip material wear, etc.

Event Description

It was reported that a mojave inner shaft broke intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• Brand Name: INNER SHAFT
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, 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: 14047017
• MDR Text Key: 289321306
• Report Number: 3004774118-2022-00132
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 10888857391703
• UDI-Public: 10888857391703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163364
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7012-90096
• Device Catalogue Number: 7012-90096
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1