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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG ULTRA-COAT MICRO EJECT KERRISON 40D UP 8 5MM RONGEURS/KERRISONS/IVDS

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S.U.A. MARTIN GMBH &CO.KG ULTRA-COAT MICRO EJECT KERRISON 40D UP 8 5MM RONGEURS/KERRISONS/IVDS Back to Search Results
Catalog Number RB5885 / 150814ABZ
Device Problem Dent in Material (2526)
Patient Problem Tissue Damage (2104)
Event Date 05/06/2015
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. (b)(4).
 
Event Description
The doctor was doing a l4-s1 decompression and laminectomy. A small tear was caused in dura (not the spinal cord) while he was operating. It was sutured immediately. No further complication after surgery. According to the doctor there was a chip in the instrument which caused the injury. He attributed the chip to the instrument being blunt.
 
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Brand NameULTRA-COAT MICRO EJECT KERRISON 40D UP 8 5MM
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 Key5472563
MDR Text Key39423597
Report Number8010386-2016-00002
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K150428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 03/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRB5885 / 150814ABZ
Device Lot NumberMR47
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 Unkown

Patient Treatment Data
Date Received: 03/02/2016 Patient Sequence Number: 1
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