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

Model Number	151-265
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the reported event it is hypothesized that during use an excessive torsional force was applied to the shaver which exceeded the mechnical strength of the distal tip.Dense bone, off-axis loading, and/or utilization of the device to open a collapsed disc space may have potentially contributed to excessive torsional loading during use resulting in the reported failure.
Event or Problem Description
It was reported that "during disc prepation, the 7mm rotate shaver broke off in the l5-s1 space.There was a 1-hour delay for microscope to be brought in to aid in seeing frgaments.The surgeon had to widen the disc space to access the broken piece.".

• Brand Name: PROLIFT
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE, INC.; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 19024637
• Report Number: 3004499989-2024-00003
• Device Sequence Number: 3772827
• Product Code: MAX
• UDI-Device Identifier: 00190837031084
• UDI-Public: (01)00190837031084
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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: 151-265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/02/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 105 KG