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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFE SPINE LIFE SPINE; AWL

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LIFE SPINE LIFE SPINE; AWL Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 03/26/2018
Event Type  malfunction  
Manufacturer Narrative
It was reported that the awl was being malleting into the sacrum during the surgery.The tip of the awl broke off and is imbedded into the patients sacrum.The fracture of the awl was caused by excessive force and the scratch pattern on the instrument indicates that the awl was not inserted straight but on angle which caused too much force on the tip.
 
Event Description
It was reported that an awl was being struck with a mallet through the product inserted on the left medial inferior screw hole.Upon malleting into the sacrum, the tip broke off the inserter into the sacrum.The straight awl tip broke off into the sacrum.The tip was unable to be removed.
 
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Brand Name
LIFE SPINE
Type of Device
AWL
Manufacturer (Section D)
LIFE SPINE
13951 south quality drive
huntley IL 60142
Manufacturer (Section G)
LIFE SPINE
13951 s. quality drive
huntley IL 60142
Manufacturer Contact
angela batker
13951 south quality drive
huntley, IL 60142
8478846117
MDR Report Key7470443
MDR Text Key107351768
Report Number3004499989-2018-00004
Device Sequence Number1
Product Code OVD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
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
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/28/2018
Initial Date FDA Received04/27/2018
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 N
Patient Sequence Number1
Patient Outcome(s) Other;
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