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: MANI, INC. MANI DIA-BURS; DENTAL DIAMOND BURS
  • 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
 

MANI, INC. MANI DIA-BURS; DENTAL DIAMOND BURS Back to Search Results
Model Number SETOF MP-1, MP-2, MP-3, MP-4, MP-5, MP-6, MP-7, MP-8, MP-9, MP-10, MP-11, MP-12F
Device Problems Vibration (1674); Insufficient Information (3190)
Patient Problems Laceration(s) (1946); Tooth Fracture (2428)
Event Date 10/15/2020
Event Type  Injury  
Event Description
During an abutment teeth preparation intended for a cosmetic treatment of tetracycline teeth, mani dia-burs (# mp-9 of abutment teeth preparation dia-burs set, not available in the u.S.) used for the procedure vibrated and bent, and front teeth of a patient fractured and the patient suffered laceration on the lower lip.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MANI DIA-BURS
Type of Device
DENTAL DIAMOND BURS
Manufacturer (Section D)
MANI, INC.
8-3 kiyohara industrial park
utsunomiya, tochigi 321-3 231
JA  321-3231
Manufacturer (Section G)
MANI, INC. TAKANEZAWA FACILITY
743 nakaakutsu
takanezawa, tochigi 329-1 234
JA   329-1234
Manufacturer Contact
hiroyuki ogiwara
8-3 kiyohara industrial park
utsunomiya, tochigi 321-3-231
JA   321-3231
MDR Report Key10836323
MDR Text Key216181410
Report Number3002692886-2020-00002
Device Sequence Number1
Product Code DZP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 11/13/2020
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
Device Operator Health Professional
Device Model NumberSETOF MP-1, MP-2, MP-3, MP-4, MP-5, MP-6, MP-7, MP-8, MP-9, MP-10, MP-11, MP-12F
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/15/2020
Initial Date FDA Received11/13/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age25 YR
-
-