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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG MICRO NDLHLDR DIAM.COATED180MM STR; DENTAL
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AESCULAP AG MICRO NDLHLDR DIAM.COATED180MM STR; DENTAL Back to Search Results
Model Number FD258R
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with fd258r -micro ndlhldr diam.Coated180mm str.According to the complaint description, locked during a coronal suture.No consequence/ no delay.There was no described patient harm.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).
 
Manufacturer Narrative
Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.
 
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Brand Name
MICRO NDLHLDR DIAM.COATED180MM STR
Type of Device
DENTAL
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key11174248
MDR Text Key227796535
Report Number9610612-2020-00979
Device Sequence Number1
Product Code DZN
Combination Product (y/n)N
PMA/PMN Number
D152001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFD258R
Device Catalogue NumberFD258R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2021
Date Manufacturer Received03/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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