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

Model Number	165-001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a revision is was noted that qty 2 modular heads disassembled insitu.
Additional Manufacturer Narrative
Based on the description of the events and the returned parts, it can be hypothesized that the root cause of the issue was improper fitment between the tulip head and taper lock.However this failure did not cause the revised surgery, additional levels were being added to the contruct.

• Brand Name: CENTERLINE MODULAR
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 quality drive; huntley 60142 ; 8478846117
• MDR Report Key: 19964984
• Report Number: 3004499989-2024-00007
• Device Sequence Number: 21035189
• Product Code: NKB
• UDI-Device Identifier: 00190837076436
• UDI-Public: (01)00190837076436(10)JI76
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: 165-001
• Device Lot Number: JI76
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female