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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 M52167
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code Head Injury (1879)
Date of Event 09/18/2021
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.Trauma.
 
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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 Key12672052
Report Number3007367732-2021-00046
Device Sequence Number4212530
Product Code MAH
UDI-Device Identifier05712149009596
UDI-Public0105712149009596111711091722110910174559
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
K152067
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/21/2021
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 Date09/09/2022
Device Model NumberM52167
Device Catalogue NumberM52167
Device Lot Number174559
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/23/2021
Initial Report FDA Received Date10/21/2021
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;
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