MAUDE Adverse Event Report: LIFE SPINE, INC. CENTERLINE MODULAR; INTERVERTEBRAL BODY FUSION DEVICE

Model Number 165-001

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 08/11/2022

Event Type  malfunction  

Manufacturer Narrative

The root cause of this reported event is likely caused by tulip head interferrence between the taper lock and the inner tulip head.This led to the tulip heads not securing as tightly as they should and resulted in teh reported event.

Event Description

4 tulip heads popped off during surgery.

• Brand Name: CENTERLINE MODULAR
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s. 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: 15379853
• MDR Text Key: 304423357
• Report Number: 3004499989-2022-00012
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190837076436
• UDI-Public: (01)00190837076436(10)JN31(01)00190837076436(10)JP11(01)00190837076436(10)JP13
• 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: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 165-001
• Device Catalogue Number: 165-001
• Device Lot Number: JN31, JP11 & JP13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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