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MAUDE
MDR
9835019
MAUDE MDR 9835019
MDR report key
9835019
Report number
1625507-2020-00032
Event key
0
Event type
3
Date of event
2020-02-14
Date received
2020-03-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3
Related Records
#
Product code HBB
Manufacturer Contact
#
Contact
STACY RUEMPING
Address
4620 NORTH BEACH STREET FT. WORTH TX 76137 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y
Devices
#
Seq, Brand, Generic table
Seq
Brand
Generic
Manufacturer
Product code
Model
Catalog
Lot
PMA
510(k)
Implant
Evaluated
Availability
1
MIDAS REX? LEGEND FOOTED ATTACHMENT
MOTOR, DRILL, PNEUMATIC
MDT POWERED SURGICAL SOLUTIONS
HBB
AF02
AF02
Y
R
Patients
#
Sequence, Received, Treatment table
Sequence
Received
Treatment
Outcome
1
2020-03-16
0
Event Narratives
#
No narrative records found.
Related GUDID Devices By Product Code
#
Primary DI, Brand, Company table
Primary DI
Brand
Company
Product code
Published
04251388960530
VELOCITY ALPHA ™
adeor Medical AG
HBB
2026-03-31
04251388910801
VELOCITY ALPHA ™
adeor Medical AG
HBB
2026-03-30
04251388924105
VELOCITY ALPHA ™
adeor Medical AG
HBB
2026-03-30
04251388959954
VELOCITY ALPHA ™
adeor Medical AG
HBB
2026-03-30
04251388959961
VELOCITY ALPHA ™
adeor Medical AG
HBB
2026-03-30
04251388959978
VELOCITY ALPHA ™
adeor Medical AG
HBB
2026-03-30
04251388960448
VELOCITY ALPHA ™
adeor Medical AG
HBB
2026-03-30
04251388961001
VELOCITY ALPHA ™
adeor Medical AG
HBB
2026-03-30
00199150001989
MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2026-03-09
00763000521622
MIDAS REX MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-08-10
20763000722313
ENT MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-07-25
20763000722337
ENT MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-07-25
00763000722326
ENT MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-07-25
00763000722340
ENT MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-07-25
20763000722399
MIDAS REX MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-07-21
20763000722429
MIDAS REX MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-07-21
00763000722401
MIDAS REX MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-07-21
00763000722418
MIDAS REX MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-07-21
00763000988784
Midas Rex MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-07-17
00763000988791
Midas Rex MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-07-17
00763000651169
Midas Rex MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-03-22
00763000521813
MIDAS REX LEGEND
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-03-20
00763000714499
MIDAS REX MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-01-16
00763000714505
MIDAS REX MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-01-16
00763000714604
MIDAS REX MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2025-01-16
00763000930837
MIDAS REX MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2024-10-03
00763000714482
MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2024-08-19
00763000714536
MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2024-08-19
00763000714550
MR8 Tools
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2024-04-27
00763000732943
MR8
MEDTRONIC POWERED SURGICAL SOLUTIONS
HBB
2024-01-18
Related PMN/PMA Records By Product Code
#
Type, Submission, Product code table
Type
Submission
Product code
Device
Applicant
Decision date
510(k)
K253772
HBB
Velocity Alpha MR High Speed Surgical Drill System
Adeor Medical AG
2026-03-06
510(k)
K172907
HBB
ELAN 4 Air Motor System
Aesculap, Inc.
2018-11-09
510(k)
K163182
HBB
Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
Medtronic Powered Surgical Solutions
2017-03-23
510(k)
K150801
HBB
Stryker Maestro Air Motors
Stryker Corporation
2015-05-22
510(k)
K101168
HBB
LEGEND POWER ADAPTER MODEL: 6475000
Medtronic Sofamor Danek
2010-08-24