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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OTICON MEDICAL AB PONTO; BONE ANCHORED HEARING IMPLANT
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OTICON MEDICAL AB PONTO; BONE ANCHORED HEARING IMPLANT Back to Search Results
Model Number M51138
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 02/22/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Implant loss is known to occur, considered in the risk management file and communicated in the ifu.There are no indications that the occurred is a result of manufacturing or component failure.These incidents do not involve serious injury and are not considered as safety issues.
 
Event or Problem Description
Implant loss.
 
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Brand Name
PONTO
Common Device Name
BONE ANCHORED HEARING IMPLANT
Manufacturer (Section D)
OTICON MEDICAL AB
datavägen 37 b
askim, 43632
SW  43632
MDR Report Key10418998
Report Number3007367732-2020-00023
Device Sequence Number3395176
Product Code MAH
UDI-Device Identifier05712149003938
UDI-Public0105712149003938111710031722100310174036
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K121228
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/30/2020
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 Lay User/Patient
Device Expiration Date10/03/2022
Device Model NumberM51138
Device Catalogue NumberM51138
Device Lot Number174036
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2020
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/30/2020
Initial Report FDA Received Date08/18/2020
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 Required Intervention;
Patient Age74 YR
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