Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OTICON MEDICAL AB PONTO; BONE ANCHORED HEARING IMPLANT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OTICON MEDICAL AB PONTO; BONE ANCHORED HEARING IMPLANT Back to Search Results
Model Number M52167
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 06/06/2020
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10419010
Report Number3007367732-2020-00030
Device Sequence Number4060055
Product Code MAH
UDI-Device Identifier05712149009596
UDI-Public0105712149009596111806291723062910182688240M5
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K152067
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) 08/17/2020
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 Date06/29/2023
Device Model NumberM52167
Device Catalogue NumberM52167
Device Lot Number182688
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 08/17/2020
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 Age46 YR
Patient Weight152
-
-