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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG VM T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 1 MM; MANUAL RONGEUR
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S.U.A. MARTIN GMBH &CO.KG VM T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 1 MM; MANUAL RONGEUR Back to Search Results
Catalog Number NL4252-81T / 2110814BT
Device Problems Bent (1059); Fracture (1260); Dent in Material (2526); Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2018
Event Type  malfunction  
Manufacturer Narrative
A deep dent in the cutting edge indicates that the instrument was used to cut hard material, such as wire.Evaluation is in progress.Should additional information become available, a follow-up report will be submitted.
 
Event Description
The device broke while being used in the patient's neck during an acdf procedure.The broken piece of the device jaw fell into the neck and was retrieved with the suction and a forceps.There was no harm to the patient nor the doctor.The procedure was completed as planned.
 
Event Description
Contrary to the original description of the event, the device was bent, not broken.No piece was missing.
 
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Brand Name
VM T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 1 MM
Type of Device
MANUAL RONGEUR
Manufacturer (Section D)
S.U.A. MARTIN GMBH &CO.KG
uhlandstrasse 17
rietheim-weilheim, 78604
GM  78604
MDR Report Key7619783
MDR Text Key111987924
Report Number8010386-2018-00006
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 06/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberNL4252-81T / 2110814BT
Device Lot NumberC17XME
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
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