MAUDE Adverse Event Report: LIFE SPINE, INC. LIFESPINE; PROLIFT

Model Number	151-265
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instrument was not returned it is not possible to determine root cause.
Event or Problem Description
Tip of shaver broken during surgery and delayed surgery 40 min.

• Brand Name: LIFESPINE
• Common Device Name: PROLIFT
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s. quality drive; huntley, il
• MDR Report Key: 10430607
• Report Number: 3004499989-2020-00006
• Device Sequence Number: 11568520
• Product Code: MAX
• UDI-Device Identifier: 00190837031084
• UDI-Public: 00190837031084
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2020

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: 151-265
• Device Catalogue Number: 151-265
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR