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

Model Number 151-265

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

The instrument was not returned it is not possible to determine root cause.

Event Description

Tip of shaver broken during surgery and delayed surgery 40 min.

• Brand Name: LIFESPINE
• Type of Device: PROLIFT
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s. quality drive; huntley, il
• Manufacturer (Section G): LIFE SPINE; 13951 south quality drive; huntley, il
• Manufacturer Contact: angela batker ; 13951 south quality drive; huntley, il ; 8846117
• MDR Report Key: 10430607
• MDR Text Key: 203652851
• Report Number: 3004499989-2020-00006
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00190837031084
• UDI-Public: 00190837031084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 151-265
• Device Catalogue Number: 151-265
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR