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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAGER & MEISINGER GMBH OKTAGON BL RC DENTAL IMPLANT 4.8X10.0MM
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HAGER & MEISINGER GMBH OKTAGON BL RC DENTAL IMPLANT 4.8X10.0MM Back to Search Results
Model Number 22006
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 01/16/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form, visual conference of the product returned by the dentist and the evaluation of relevant production records.(b)(4).
 
Event or Problem Description
Difficult removing the mount.
 
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Brand Name
OKTAGON BL RC DENTAL IMPLANT 4.8X10.0MM
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
HAGER & MEISINGER GMBH
hansemannstr. 10
neuss, nordrhein-westfalen 41468
GM  41468
MDR Report Key10318673
Report Number8010516-2020-00001
Device Sequence Number689884
Product Code DZE
UDI-Device IdentifierE0HM220061
UDI-Public+E0HM220061/$B41957/14D20230831/
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K143539
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date08/31/2023
Device Model Number22006
Device Lot NumberB41957
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/24/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age55 YR
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