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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FEHLING INSTRUMENTS GMBH & CO. KG CERAMO FEHLING PUNCH EJECTOR PUNCH

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FEHLING INSTRUMENTS GMBH & CO. KG CERAMO FEHLING PUNCH EJECTOR PUNCH Back to Search Results
Model Number NNR-0F
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2022
Event Type  malfunction  
Event Description
A cervical kerrision broke during the procedure while in use. All pieces wer retrieved by the surgeon.
 
Manufacturer Narrative
Based on the lot number, we have checked the dhr: no findings we will examine the device as soon as possible.
 
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Brand NameCERAMO FEHLING PUNCH
Type of DeviceEJECTOR PUNCH
Manufacturer (Section D)
FEHLING INSTRUMENTS GMBH & CO. KG
hanauer landstr. 7a
karlstein, bavaria 63791
GM 63791
Manufacturer (Section G)
FEHLING INSTRUMENTS GMBH & CO. KG
hanauer landstr. 7a
karlstein, bavaria 63791
GM 63791
Manufacturer Contact
esther bauer
hanauer landstr. 7a
karlstein, bavaria 63791
GM   63791
MDR Report Key13657803
MDR Text Key289204646
Report Number9615005-2022-80006
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Administrator/Supervisor
Remedial Action Replace
Type of Report Initial
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNNR-0F
Device Catalogue NumberNNR-0F
Device Lot NumberX17J543WM
Was Device Available for Evaluation? No
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/09/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/03/2022 Patient Sequence Number: 1
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