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U.S. Department of Health and Human Services

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

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FEHLING INSTRUMENTS, GMBH & CO. KG CERAMO EJECTOR PUNCH RONGEUR, MANUAL Back to Search Results
Catalog Number NNR-0F
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2022
Event Type  Injury  
Event Description
A cervical kerrison broke during the procedure while in use. All pieces were retrieved by surgeon. Fda safety report id# (b)(4).
 
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Brand NameCERAMO EJECTOR PUNCH
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
FEHLING INSTRUMENTS, GMBH & CO. KG
MDR Report Key13366615
MDR Text Key284630053
Report NumberMW5107005
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 01/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberNNR-0F
Device Lot Number8X17J543WM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2022
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/26/2022 Patient Sequence Number: 1
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