MAUDE Adverse Event Report: LIFE SPINE CENTERLINE; INTERVERTEBRAL BODY FUSION DEVICE

Model Number NC055-040-4

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Malunion of Bone (4529)

Event Date 10/29/2021

Event Type  Injury  

Manufacturer Narrative

The root cause appears to have been that two screws experienced excessive load either by traumatic fracture or improper implanting.

Event Description

It was reported that the surgeon who initially implanted hardware scheduled a revision of centerline.Surgeon's colleague assisted and decided they wanted to remove all hardware and replace with a different product upon exposure and removing hardware, they noticed one complete side of screws (3) had broken.Other side intact.Hardware is being washed, collected & returned.

• Brand Name: CENTERLINE
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): LIFE SPINE; 13951 south quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 south quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 south quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 12846380
• MDR Text Key: 285534115
• Report Number: 3004499989-2021-00011
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190837076603
• UDI-Public: (01)00190837076603(10)IZ51
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NC055-040-4
• Device Catalogue Number: NC055-040-4
• Device Lot Number: IZ51
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male