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

Model Number	NC055-040-4
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Malunion of Bone (4529)
Date of Event	10/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause appears to have been that two screws experienced excessive load either by traumatic fracture or improper implanting.
Event or Problem 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
• Common Device Name: 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
• Report Number: 3004499989-2021-00011
• Device Sequence Number: 4351956
• Product Code: NKB
• UDI-Device Identifier: 00190837076603
• UDI-Public: (01)00190837076603(10)IZ51
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NC055-040-4
• Device Catalogue Number: NC055-040-4
• Device Lot Number: IZ51
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male