• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG RUGGLES STEALTH MICRO KERRISON RONGEURS THIN FOOTPLATE RONGEURS/KERRISONS/IVDS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

S.U.A. MARTIN GMBH &CO.KG RUGGLES STEALTH MICRO KERRISON RONGEURS THIN FOOTPLATE RONGEURS/KERRISONS/IVDS Back to Search Results
Catalog Number RB4882/0150814BS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2013
Event Type  malfunction  
Manufacturer Narrative
To date the device involved in the reported incident has not been received for evaluation. The device history record, including acceptance testing results, was reviewed and found to conform to specifications. No complaints with regard to similar failures have been received. Since the device was not available for testing and evaluation, neither the product problem nor its cause can be established. Device not returned to manufacturer.
 
Event Description
The top portion of the cutting part of the device curled up. Customer reports the surgeon was performing a spinal fusion using the device to remove bone, etc. To expose the dura. The doctor was very upset, since he states he almost tore the patient's dural sac. However, there was no patient harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRUGGLES STEALTH MICRO KERRISON RONGEURS THIN FOOTPLATE
Type of DeviceRONGEURS/KERRISONS/IVDS
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
4619668540
MDR Report Key5472562
MDR Text Key39852670
Report Number8010386-2016-00001
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRB4882/0150814BS
Device Lot Number20121445
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 Received12/08/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-