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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOBEL BIOCARE AB REPLACE SELECT TAPERED PMC 6.0 6X10MM; ENDOSSEOUS DENTAL IMPLANT
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NOBEL BIOCARE AB REPLACE SELECT TAPERED PMC 6.0 6X10MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Model Number 37316
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)
Date of Event 03/12/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
 
Event or Problem Description
Implant failed due to a loss of osseointegration.
 
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Brand Name
REPLACE SELECT TAPERED PMC 6.0 6X10MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NOBEL BIOCARE AB
dimbovgen 2
karlskoga, SE-69 151
SW  SE-69151
MDR Report Key9895639
Report Number9611993-2020-17891
Device Sequence Number754339
Product Code DZE
UDI-Device Identifier07332747073331
UDI-Public(01)07332747073331(10)12092239(17)220730
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K023113
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 03/12/2020
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 Health Professional
Device Expiration Date07/30/2022
Device Model Number37316
Device Catalogue Number37316
Device Lot Number12092239
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/12/2020
Initial Report FDA Received Date03/29/2020
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 Age72 YR
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