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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OTICON MEDICAL AB PONTO ABUTMENT; BONE ANCHORED HEARING IMPLANT
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OTICON MEDICAL AB PONTO ABUTMENT; BONE ANCHORED HEARING IMPLANT Back to Search Results
Model Number M50362
Device Problems Shelf Life Exceeded (1567); Expiration Date Error (2528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/07/2015
Event Type  malfunction  
Event Description
Reported by surgical facility that at time of abutment swap the product provided by oticon medical was expired.The facility reports that the date of the expiration was (b)(6)2015.The date of the abutment swap was (b)(6) 2015 so the component used at time of the procedure was expired.Surgeon elected to use the abutment.
 
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Brand Name
PONTO ABUTMENT
Type of Device
BONE ANCHORED HEARING IMPLANT
Manufacturer (Section D)
OTICON MEDICAL AB
datavagen 37b
askim SE-43 6 32
SW  SE-436 32
Manufacturer Contact
carolina wessling
datavagen 37b
askim SE-43-6 32
SW   SE-436 32
17486175
MDR Report Key4993241
MDR Text Key23535434
Report Number3007367732-2015-00028
Device Sequence Number1
Product Code MAH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112053
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Report Date 07/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/01/2015
Device Model NumberM50362
Device Catalogue NumberM50362
Device Lot Number102318
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/07/2015
Event Location Hospital
Date Report to Manufacturer07/09/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/05/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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