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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cerclage, fixation
Product CodeJDQ
Regulation Number 888.3010
Device Class 2


Premarket Reviews
ManufacturerDecision
A & E MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
A&E MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ARTHREX, INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET SPORTS MEDICINE
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
CABLE FIX MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CIRCUMFIX SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DALLEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DALLEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FIGURE 8 SURGICAL, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
FRONTIER MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
IMPLANET S.A.
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 1
KINAMED INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
KINAMED, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
NEOS SURGERY SL
  SUBSTANTIALLY EQUIVALENT 2
PIONEER SURGICAL TECHNOLOGY, INC
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
  SUBSTANTIALLY EQUIVALENT 3
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIC BREVETTI S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA)
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 223 223
2015 205 205
2016 223 223
2017 138 138
2018 182 182
2019 159 159
2020 124 124
2021 141 141
2022 134 134
2023 98 98
2024 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Break 382 382
Adverse Event Without Identified Device or Use Problem 380 380
Device Operates Differently Than Expected 249 249
Mechanical Problem 196 196
Insufficient Information 90 90
Fracture 67 67
Device-Device Incompatibility 43 43
Failure To Adhere Or Bond 34 34
Device Slipped 30 30
Mechanical Jam 29 29
Migration 23 23
Unintended Movement 21 21
Migration or Expulsion of Device 21 21
Loose or Intermittent Connection 20 20
Appropriate Term/Code Not Available 19 19
Material Deformation 19 19
Sticking 16 16
Component Missing 15 15
Material Frayed 12 12
No Apparent Adverse Event 12 12
Device Dislodged or Dislocated 11 11
Crack 9 9
Material Fragmentation 9 9
Bent 9 9
Difficult to Advance 8 8
Material Integrity Problem 7 7
Material Separation 7 7
Device Difficult to Maintain 7 7
Failure to Cut 6 6
Detachment of Device or Device Component 6 6
Difficult to Open or Close 5 5
Device Handling Problem 5 5
Detachment Of Device Component 4 4
Dull, Blunt 4 4
Device Operational Issue 4 4
Difficult to Remove 4 4
Device Issue 4 4
Corroded 4 4
Loss of or Failure to Bond 3 3
Device Reprocessing Problem 3 3
Failure to Advance 3 3
Fitting Problem 3 3
Difficult to Insert 3 3
Entrapment of Device 3 3
Device Disinfection Or Sterilization Issue 3 3
Inadequacy of Device Shape and/or Size 3 3
Device Contamination with Chemical or Other Material 3 3
Loss of Osseointegration 2 2
Device Inoperable 2 2
Failure to Osseointegrate 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 333 333
No Clinical Signs, Symptoms or Conditions 225 225
Unspecified Infection 189 189
No Code Available 182 182
Pain 175 175
No Patient Involvement 158 158
No Consequences Or Impact To Patient 149 149
Non-union Bone Fracture 101 101
Failure of Implant 100 100
Injury 48 48
Bone Fracture(s) 46 46
Impaired Healing 44 44
No Information 36 36
Insufficient Information 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Wound Dehiscence 18 18
Post Operative Wound Infection 17 17
Reaction 16 16
Death 16 16
Inflammation 15 15
Fall 14 14
Device Embedded In Tissue or Plaque 14 14
Hypersensitivity/Allergic reaction 13 13
Hemorrhage/Bleeding 11 11
Joint Dislocation 11 11
Discomfort 10 10
Hematoma 9 9
Swelling 8 8
Ambulation Difficulties 7 7
Metal Related Pathology 7 7
Sepsis 7 7
Unspecified Tissue Injury 7 7
Hip Fracture 7 7
Foreign Body In Patient 7 7
Loss of Range of Motion 7 7
Not Applicable 6 6
Adhesion(s) 6 6
Malunion of Bone 5 5
Edema 5 5
Patient Problem/Medical Problem 5 5
Irritation 5 5
Necrosis 4 4
Inadequate Osseointegration 4 4
Bacterial Infection 4 4
Tissue Damage 4 4
Osteolysis 4 4
Joint Disorder 3 3
Arthritis 3 3
Fluid Discharge 3 3
Toxicity 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Alto Development Corp II Oct-30-2019
2 EXP Pharmaceutical Services Corp II Jul-24-2015
3 PIONEER SURGICAL TECHNOLOGY, INC. II Jul-17-2014
4 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Jul-09-2015
5 Smith & Nephew Inc II Aug-10-2010
6 Synthes (USA) Products LLC II Nov-14-2015
7 Synthes (USA) Products LLC II Aug-27-2015
8 Synthes USA HQ, Inc. II Oct-30-2013
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