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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. NEURO PACK

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MEDLINE INDUSTRIES INC. NEURO PACK Back to Search Results
Catalog Number DYNJ0397191T
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2019
Event Type  Malfunction  
Manufacturer Narrative

It was reported that during a spinal fusion, a #11 surgical blade (taken from a neuro pack) broke in half. At the time of the incident, the surgeon was reportedly cutting the disc in the spine when the blade broke in half off of the scalpel. The surgeon was able to remove the blade; however the removal added an additional 20-30 minutes and x-rays were required to remove the sharp pointed end out of the patient's spine. Per the facility's report, all pieces of the blade were successfully retrieved without further incident. No impact to the patient, the staff, or the procedure was reported. There was no serious injury or follow-up care reported related to the event. General anesthesia was used; however, there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident. Due to the reported event and required medical intervention, this medwatch is being filed. The sample was not returned to the manufacturer for evaluation. A root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.

 
Event Description

It was reported that the surgical blade broke in half. The blade was successfully retrieved without further intervention.

 
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Type of DeviceNEURO PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
karen trutsch
three lakes drive
northfield, IL 60093
MDR Report Key8475203
MDR Text Key145771490
Report Number1423395-2019-00007
Device Sequence Number1
Product Code OJG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 04/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberDYNJ0397191T
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/02/2019 Patient Sequence Number: 1
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