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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG KERRISON RONGEUR, LUMBAR, 40" UP, 4 MM, 8 INCHES 203 MM

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S.U.A. MARTIN GMBH &CO.KG KERRISON RONGEUR, LUMBAR, 40" UP, 4 MM, 8 INCHES 203 MM Back to Search Results
Catalog Number 53-1417 / 0140814C
Device Problems Inadequate Service (1564); Misassembly by Users (3133)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/04/2017
Event Type  malfunction  
Manufacturer Narrative
This follow-up report is being submitted to provide fda additional data not available at time of submission of initial report, specifically: date of event, initial reporter, and adverse event report number of us importer.
 
Manufacturer Narrative
The device was returned without the screw and root cause of the failure could not be established. Traces of the original screw fixation mechanism were observed. It may be that the instrument was disassembled for cleaning despite ifu instructions for it not to be taken apart. Manufacturing and quality control records were reviewed and found to be conforming to specifications. Additional information has been requested on event and patient outcome. Should additional information become available, a follow-up report will be submitted.
 
Event Description
During surgery, the screw on the slide came out after several uses, falling into the patient. No additional details are available at this time. No harm to patient has been reported.
 
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Brand NameKERRISON RONGEUR, LUMBAR, 40" UP, 4 MM, 8 INCHES 203 MM
Type of DeviceKERRISON 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 Key6787639
MDR Text Key249774027
Report Number8010386-2017-00003
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number53-1417 / 0140814C
Device Lot NumberM5546
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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