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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFE SPINE, INC. PROLIFT; INTERVERTEBRAL BODY FUSION DEVICE
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LIFE SPINE, INC. PROLIFT; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Model Number 151-271
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2022
Event Type  malfunction  
Manufacturer Narrative
Based on the returned device, it is likely that the applied torsional force on the paddlehead of the device during disc preparation exceeded the mechanical properties of the shaver.
 
Event Description
It was reported that 9mm prolift shaver broke off when used.
 
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Brand Name
PROLIFT
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 Key15262881
MDR Text Key303087930
Report Number3004499989-2022-00011
Device Sequence Number1
Product Code MAX
UDI-Device Identifier00190837031107
UDI-Public00190837031107
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190488
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number151-271
Device Catalogue Number151-271
Device Lot NumberCNW18061
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2022
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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