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

TPLC - Total Product Life Cycle
  • 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
 

New Search show TPLC since Back to Search Results
Device staple, fixation, bone
Product CodeJDR
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL ENT., INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMEDICAL ENTERPRISES, INC
  SUBSTANTIALLY EQUIVALENT 2
BIOMEDICAL ENTERPRISES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 3
CROSSROADS EXTEMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2
DALLEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
EPIC EXTREMELY, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXOTOE LLC
  SUBSTANTIALLY EQUIVALENT 1
F & A FOUNDATION LLC D.B.A. REIGN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FIRST RAY LLC
  SUBSTANTIALLY EQUIVALENT 2
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 3
IN2BONESUSA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INSTRATEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISCOPE MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 3
MERETE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
METASURG
  SUBSTANTIALLY EQUIVALENT 1
METRIC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MX ORTHOPEDICS, CORP.
  SUBSTANTIALLY EQUIVALENT 2
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NEXTREMITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
NOVATSEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS UK LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHODISCOVERY GROUP LLC(D.B.A. CROSSROADS EXTREMITY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ORTHOHELIX SURGICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOVESTMENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
OT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28 INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
RESTORE SURGICAL LLC DBA INSTRATEK
  SUBSTANTIALLY EQUIVALENT 1
RMR ORTHO, LLC
  SUBSTANTIALLY EQUIVALENT 1
SOLANA SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 2
SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 2
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TRILLIANT SURGICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
VILEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 49 49
2015 48 48
2016 76 76
2017 116 116
2018 239 239
2019 242 242
2020 234 234
2021 210 210
2022 202 209
2023 175 175
2024 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Break 549 549
Adverse Event Without Identified Device or Use Problem 276 280
Detachment of Device or Device Component 131 131
Fracture 97 97
Device Dislodged or Dislocated 40 40
Migration or Expulsion of Device 37 37
Material Frayed 37 37
Migration 35 38
Insufficient Information 32 32
Appropriate Term/Code Not Available 32 32
Device-Device Incompatibility 31 31
Manufacturing, Packaging or Shipping Problem 29 29
Difficult to Advance 23 23
Material Split, Cut or Torn 23 23
Device Operates Differently Than Expected 20 20
Physical Resistance/Sticking 19 19
Unknown (for use when the device problem is not known) 18 18
Material Separation 17 17
Crack 16 16
Loosening of Implant Not Related to Bone-Ingrowth 15 15
Activation, Positioning or Separation Problem 14 14
Positioning Failure 13 13
Material Deformation 11 11
Mechanical Jam 9 9
Entrapment of Device 9 9
Failure to Advance 9 9
Improper or Incorrect Procedure or Method 8 8
Difficult to Insert 8 8
Patient Device Interaction Problem 8 8
Packaging Problem 8 8
Unintended Movement 8 8
Loose or Intermittent Connection 7 7
Material Fragmentation 7 7
Detachment Of Device Component 7 7
Device Slipped 7 7
Patient-Device Incompatibility 6 6
No Apparent Adverse Event 6 6
Material Twisted/Bent 5 5
Device Contaminated During Manufacture or Shipping 5 5
Separation Failure 5 5
Component Falling 5 5
Difficult or Delayed Positioning 5 5
Mechanical Problem 5 5
Difficult to Remove 5 5
Material Rupture 4 4
Difficult To Position 4 4
Failure to Form Staple 4 4
Connection Problem 4 4
Material Integrity Problem 4 4
Device Damaged by Another Device 4 4
Activation Problem 4 4
Inaccurate Information 4 4
Device Contamination with Chemical or Other Material 3 3
Device Markings/Labelling Problem 3 3
Failure to Align 3 3
Misfire 3 3
Component Missing 3 3
Delivered as Unsterile Product 3 3
Corroded 3 3
Bent 3 3
Material Disintegration 2 2
Unintended Ejection 2 2
Flaked 2 2
Overheating of Device 2 2
Premature Activation 2 2
Use of Device Problem 2 2
Defective Component 2 2
Fitting Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Failure to Cut 2 2
Contamination /Decontamination Problem 2 2
Device Packaging Compromised 2 2
Therapeutic or Diagnostic Output Failure 2 2
Positioning Problem 2 2
Failure to Eject 2 2
Firing Problem 2 2
Device Fell 2 2
Temperature Problem 1 1
Output Problem 1 1
Device Difficult to Maintain 1 1
Device Operational Issue 1 1
Expulsion 1 1
Moisture or Humidity Problem 1 1
Material Protrusion/Extrusion 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Disinfection Or Sterilization Issue 1 1
Defective Device 1 1
Device Or Device Fragments Location Unknown 1 1
Failure to Fire 1 1
Malposition of Device 1 1
Expiration Date Error 1 1
Sticking 1 1
Stretched 1 1
Device Inoperable 1 1
Unstable 1 1
Device Damaged Prior to Use 1 1
Device Issue 1 1
Tear, Rip or Hole in Device Packaging 1 1
Loss of Osseointegration 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 428 428
No Consequences Or Impact To Patient 243 243
No Known Impact Or Consequence To Patient 215 215
No Code Available 115 115
Pain 109 109
Non-union Bone Fracture 70 70
Injury 67 67
Tissue Damage 59 59
Failure of Implant 58 58
Not Applicable 56 56
Foreign Body In Patient 50 50
Insufficient Information 46 46
No Information 43 43
Unspecified Infection 36 36
Bone Fracture(s) 28 28
No Patient Involvement 26 26
Loss of Range of Motion 25 28
Post Operative Wound Infection 24 24
Unspecified Tissue Injury 23 23
Impaired Healing 18 18
Perforation 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Implant Pain 11 15
Discomfort 11 11
Reaction 10 10
Device Embedded In Tissue or Plaque 10 10
Hypersensitivity/Allergic reaction 8 8
Wound Dehiscence 8 8
Swelling 6 6
Unknown (for use when the patient's condition is not known) 6 6
Patient Problem/Medical Problem 5 5
Osteolysis 5 5
Foreign Body Reaction 5 5
Hematoma 4 4
Cyst(s) 4 4
Fall 4 4
Abscess 4 4
Bacterial Infection 4 4
Erosion 4 4
Inflammation 4 4
Rupture 4 4
Joint Dislocation 4 4
Malunion of Bone 4 4
Skin Infection 3 3
Swelling/ Edema 3 3
Weakness 3 3
Surgical procedure, delayed 3 3
Nerve Damage 3 3
Synovitis 3 3
Cellulitis 3 3
Arthritis 3 3
Fever 2 2
Stroke/CVA 2 2
Local Reaction 2 2
Surgical procedure, repeated 2 2
Muscular Rigidity 2 2
Irritation 2 2
Laceration(s) 2 2
Ulcer 2 2
Deformity/ Disfigurement 2 2
Numbness 2 2
Skin Inflammation/ Irritation 2 2
Physical Asymmetry 2 2
Muscle/Tendon Damage 1 1
Osteomyelitis 1 1
Hypoesthesia 1 1
Arthralgia 1 1
Joint Disorder 1 1
Therapeutic Response, Decreased 1 1
Inadequate Osseointegration 1 1
Needle Stick/Puncture 1 1
Organ Dehiscence 1 1
Ambulation Difficulties 1 1
Joint Contracture 1 1
Damage to Ligament(s) 1 1
Lupus 1 1
Necrosis 1 1
Scarring 1 1
Seroma 1 1
Skin Discoloration 1 1
Allergic reaction 1 1
Ossification 1 1
Erythema 1 1
Hyperplasia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-18-2022
2 Biomet, Inc. II Apr-02-2015
3 Crossroads Extremity Systems Llc II Mar-20-2017
4 In2bones USA, LLC II Dec-22-2018
5 Integra LifeSciences Corp. III Mar-04-2017
6 Merete Medical GmbH II Feb-17-2022
7 Paragon 28, Inc. II Jun-20-2018
8 Smith & Nephew, Inc. Endoscopy Division II Sep-17-2013
9 Stryker GmbH II Nov-16-2020
10 Stryker Howmedica Osteonics Corp. II Feb-23-2016
11 Synthes (USA) Products LLC II Oct-18-2022
12 Synthes (USA) Products LLC II Oct-06-2022
13 TriMed Inc. II Jun-20-2018
14 Wright Medical Technology, Inc. II Mar-31-2022
-
-