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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG T-COAT MICRO HDL. KERRISON RONGEUR 8IN 4MM BITE 40 DEG. UP

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S.U.A. MARTIN GMBH &CO.KG T-COAT MICRO HDL. KERRISON RONGEUR 8IN 4MM BITE 40 DEG. UP Back to Search Results
Catalog Number NL4251-84T / 0140814BT
Device Problems Inadequate Service (1564); Improper or Incorrect Procedure or Method (2017); Misassembly by Users (3133)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2017
Event Type  malfunction  
Manufacturer Narrative
The device was inspected and evidence of third-party rework and repair was observed.Apparently the screw had been removed and not correctly fixated again after these unauthorized activities.Original manufacturing and quality control records were reviewed and found to be conforming.
 
Event Description
During a posterior lumbar fusion/fixation, the upper screw of the rongeur came loose and fell into the patient.It was retrieved immediately from the surgical field.The procedure was completed as planned and there was no harm to patient.
 
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Brand Name
T-COAT MICRO HDL. KERRISON RONGEUR 8IN 4MM BITE 40 DEG. UP
Type of Device
KERRISON RONGEUR
Manufacturer (Section D)
S.U.A. MARTIN GMBH &CO.KG
uhlandstrasse 17
rietheim-weilheim, 78604
GM  78604
Manufacturer (Section G)
S.U.A. MARTIN GMBH &CO.KG
uhlandstrasse 17
rietheim-weilheim, 78604
GM   78604
Manufacturer Contact
markus pauli
uhlandstrasse 17
rietheim-weilheim, 78604
GM   78604
MDR Report Key6788253
MDR Text Key82706915
Report Number8010386-2017-00004
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 08/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberNL4251-84T / 0140814BT
Device Lot NumberM5R37 / XMEV11
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/21/2017
Initial Date FDA Received08/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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