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TPLC
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Device
motor, drill, pneumatic
Product Code
HBB
Regulation Number
882.4370
Device Class
2
Premarket Reviews
Manufacturer
Decision
AESCULAP, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC POWERED SURGICAL SOLUTIONS
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC SOFAMOR DANEK
SUBSTANTIALLY EQUIVALENT
1
STRYKER CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SYNTHES (USA)
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
562
562
2015
440
440
2016
273
452
2017
203
477
2018
295
652
2019
284
722
2020
263
372
2021
260
419
2022
172
332
2023
180
306
2024
56
102
Device Problems
MDRs with this Device Problem
Events in those MDRs
Output below Specifications
459
459
Bent
398
398
Overheating of Device
326
803
Leak/Splash
231
1060
Material Puncture/Hole
166
166
Device Operates Differently Than Expected
145
145
Break
136
134
Detachment of Device or Device Component
135
175
Noise, Audible
132
132
Fluid/Blood Leak
126
526
Unintended System Motion
114
114
Device Abrasion From Instrument Or Another Object
105
105
Device Inoperable
86
86
Fail-Safe Problem
81
100
No Apparent Adverse Event
75
75
Unintended Power Up
66
126
Air Leak
49
49
Vibration
43
43
Device Remains Activated
41
42
Hole In Material
35
35
Material Twisted/Bent
35
38
Naturally Worn
34
34
Burst Container or Vessel
34
48
Mechanical Jam
33
33
Excessive Heating
31
31
Complete Loss of Power
30
30
Physical Resistance/Sticking
28
29
Power Problem
28
28
Mechanical Problem
27
27
Fracture
25
25
Loss of Power
25
25
Sticking
23
25
Disassembly
22
31
Electrical /Electronic Property Problem
21
21
Partial Blockage
20
20
Detachment Of Device Component
15
15
Material Rupture
15
15
Self-Activation or Keying
15
15
Failure to Power Up
14
14
Appropriate Term/Code Not Available
14
14
Insufficient Information
13
13
Adverse Event Without Identified Device or Use Problem
13
13
Failure to Shut Off
12
12
Temperature Problem
12
12
Difficult to Insert
12
12
Device Maintenance Issue
12
12
Difficult to Remove
11
11
Device Slipped
10
10
Defective Component
10
10
Unintended Movement
10
18
Defective Device
8
8
Misconnection
8
8
Cut In Material
7
7
Loose or Intermittent Connection
7
7
Material Fragmentation
7
7
Unexpected Shutdown
7
7
Device Damaged by Another Device
7
7
Material Deformation
6
6
Fitting Problem
6
6
Device Stops Intermittently
6
6
Pressure Problem
5
5
Device Contamination with Chemical or Other Material
5
5
Premature Separation
5
5
Intermittent Loss of Power
4
4
Gas/Air Leak
4
4
Device-Device Incompatibility
4
4
Connection Problem
4
4
Failure to Auto Stop
4
4
Smoking
4
4
Energy Output Problem
4
4
Power Conditioning Problem
4
4
Material Separation
3
3
Incorrect Or Inadequate Test Results
3
3
Component Missing
3
3
Degraded
3
3
Migration or Expulsion of Device
3
5
Corroded
3
3
Failure of Device to Self-Test
3
3
Protective Measures Problem
3
3
Physical Resistance
3
3
Device Fell
3
3
Torn Material
3
3
Positioning Problem
3
3
Fail-Safe Did Not Operate
3
3
Device Operational Issue
2
2
Malposition of Device
2
2
Material Integrity Problem
2
2
Material Discolored
2
2
Entrapment of Device
2
2
Dull, Blunt
2
2
Obstruction of Flow
2
2
Metal Shedding Debris
2
2
Unstable
2
2
Structural Problem
1
1
Split
1
1
Difficult or Delayed Activation
1
1
Material Perforation
1
1
Device Displays Incorrect Message
1
1
Nonstandard Device
1
1
Unintended Collision
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
953
1791
No Clinical Signs, Symptoms or Conditions
685
1316
No Known Impact Or Consequence To Patient
639
1090
No Consequences Or Impact To Patient
599
919
No Information
43
129
Insufficient Information
15
58
Perforation
15
15
Burn(s)
14
14
Injury
13
13
Chemical Exposure
13
13
Device Embedded In Tissue or Plaque
13
13
Hearing Impairment
11
11
Tissue Damage
8
8
Foreign Body In Patient
8
8
Cerebrospinal Fluid Leakage
7
7
Hemorrhage/Bleeding
6
6
Radiation Exposure, Unintended
6
6
Unspecified Tissue Injury
6
6
Unintended Radiation Exposure
6
6
Unspecified Infection
5
5
Burn, Thermal
5
7
Nerve Damage
5
5
Spinal Column Injury
4
4
Tinnitus
3
3
Laceration(s)
3
3
Death
3
3
No Code Available
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Superficial (First Degree) Burn
2
8
Erythema
2
2
Acoustic Trauma
2
3
Hematoma
2
2
Pain
2
2
Spinal Cord Injury
2
2
Reaction
1
1
Numbness
1
1
Sprain
1
1
Muscle Weakness
1
1
Internal Organ Perforation
1
1
Oversedation
1
1
Inflammation
1
1
Intracranial Hemorrhage
1
1
Hemorrhage, Subdural
1
1
Failure of Implant
1
1
Facial Nerve Paralysis
1
1
Fatigue
1
1
Headache
1
1
Contusion
1
1
Hearing Loss
1
1
Partial thickness (Second Degree) Burn
1
3
Not Applicable
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Feb-15-2018
2
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
II
May-04-2016
3
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
II
Nov-20-2015
4
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
II
Dec-17-2009
5
Stryker Instruments Div. of Stryker Corporation
II
Jun-09-2016
6
The Anspach Effort, Inc.
II
Jun-25-2014
7
The Anspach Effort, Inc.
II
Jan-09-2014
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