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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOBEL BIOCARE PROCERA ABUTMENT ZR BMK SYST RP W-U LIGHT
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NOBEL BIOCARE PROCERA ABUTMENT ZR BMK SYST RP W-U LIGHT Back to Search Results
Catalog Number 10-6004-5
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/28/2016
Event Type  malfunction  
Manufacturer Narrative
Referencing quality notification # 201691136.Continued monitoring of all complaints of this type will continue to be conducted.No further corrective or preventive actions are planned.
 
Event Description
Pigmentation, blue/gray discoloration of the mucosa.According to the clinician, the discoloration is not amalgam tattoos.
 
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Brand Name
PROCERA ABUTMENT ZR BMK SYST RP W-U LIGHT
Type of Device
PROCERA ABUTMENT
Manufacturer (Section D)
NOBEL BIOCARE
procera sandvik ab
12680 stockholm, sweden 40226
SW  40226
Manufacturer Contact
joann radovich
22715 savi ranch parkway
yorba linda, CA 92887
7142824800
MDR Report Key6394643
MDR Text Key69878305
Report Number3003719670-2017-00001
Device Sequence Number1
Product Code NHA
Combination Product (y/n)N
PMA/PMN Number
K073719
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Dentist
Remedial Action Other
Type of Report Initial
Report Date 09/29/2016
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 Dentist
Device Catalogue Number10-6004-5
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/28/2016
Initial Date FDA Received03/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2014
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) Other;
Patient Age67 YR
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