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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 M51136
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 06/14/2017
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, but they are reported due to the intervention required for the patient to be able to continue using the bone anchored hearing system.
 
Event or Problem Description
Implant loss.Primary stability was not achieved at time of surgery.Implant fell out spontaneously.
 
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Brand Name
PONTO
Common Device Name
BONE ANCHORED HEARING IMPLANT
Manufacturer (Section D)
OTICON MEDICAL AB
datavagen 37b
askim, 43632
SW  43632
MDR Report Key7002499
Report Number3007367732-2017-00092
Device Sequence Number13771892
Product Code MAH
UDI-Device Identifier05712149003914
UDI-Public0105712149003914111512031720120310154939
Combination Product (Y/N)N
Initial Reporter CountrySN
PMA/510(K) Number
K152067
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/13/2017
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 Date12/03/2020
Device Model NumberM51136
Device Catalogue NumberM51136
Device Lot Number154939
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2017
Initial Report FDA Received Date11/06/2017
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 Age58 YR
Patient Weight34
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