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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cerclage, fixation
Regulation Description Bone fixation cerclage.
Product CodeJDQ
Regulation Number 888.3010
Device Class 2


Premarket Reviews
ManufacturerDecision
A&E MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC
  SUBSTANTIALLY EQUIVALENT 1
CIRCUMFIX SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
NEOS SURGERY SL
  SUBSTANTIALLY EQUIVALENT 2
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
  SUBSTANTIALLY EQUIVALENT 2
RIVERPOINT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 124 124
2021 141 141
2022 134 134
2023 98 98
2024 115 115
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 166 166
Adverse Event Without Identified Device or Use Problem 156 156
Break 153 153
Device-Device Incompatibility 33 33
Fracture 30 30
Migration 24 24
Device Slipped 19 19
Insufficient Information 16 16
Material Deformation 12 12
Crack 6 6
Migration or Expulsion of Device 5 5
Material Frayed 5 5
Material Fragmentation 5 5
Failure to Cut 5 5
No Apparent Adverse Event 5 5
Appropriate Term/Code Not Available 4 4
Material Separation 3 3
Entrapment of Device 3 3
Product Quality Problem 2 2
Detachment of Device or Device Component 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Material Integrity Problem 2 2
Patient Device Interaction Problem 2 2
Device Appears to Trigger Rejection 2 2
Failure to Osseointegrate 2 2
Defective Component 2 2
Patient-Device Incompatibility 2 2
Malposition of Device 1 1
Physical Resistance/Sticking 1 1
No Fail-Safe Mechanism 1 1
Mechanical Jam 1 1
Connection Problem 1 1
Loss of Osseointegration 1 1
Temperature Problem 1 1
Material Disintegration 1 1
Unraveled Material 1 1
Device Contamination with Chemical or Other Material 1 1
Device Difficult to Setup or Prepare 1 1
Unintended Movement 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Nonstandard Device 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Naturally Worn 1 1
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 268 268
Unspecified Infection 66 66
Pain 44 44
Non-union Bone Fracture 43 43
Insufficient Information 40 40
No Code Available 37 37
Failure of Implant 31 31
No Consequences Or Impact To Patient 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
No Known Impact Or Consequence To Patient 13 13
Post Operative Wound Infection 12 12
Bone Fracture(s) 11 11
No Patient Involvement 11 11
Hypersensitivity/Allergic reaction 10 10
Metal Related Pathology 9 9
Fall 9 9
Unspecified Tissue Injury 7 7
Hemorrhage/Bleeding 7 7
Adhesion(s) 6 6
Death 6 6
Hip Fracture 6 6
Inflammation 5 5
Discomfort 5 5
Foreign Body In Patient 5 5
Malunion of Bone 5 5
Injury 4 4
Loss of Range of Motion 4 4
Swelling/ Edema 4 4
Joint Dislocation 3 3
Hematoma 3 3
Inadequate Osseointegration 3 3
Bacterial Infection 3 3
Impaired Healing 3 3
Fluid Discharge 3 3
Wound Dehiscence 2 2
Cellulitis 2 2
Scar Tissue 2 2
Joint Contracture 2 2
Nerve Damage 2 2
Edema 2 2
Ossification 2 2
Osteolysis 1 1
Muscle/Tendon Damage 1 1
Bruise/Contusion 1 1
Balance Problems 1 1
Erosion 1 1
Abscess 1 1
Foreign Body Reaction 1 1
Pneumonia 1 1
Cyst(s) 1 1

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