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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device appliance, fixation, spinal interlaminal
Product CodeKWP
Regulation Number 888.3050
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCEL SPINE
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET SPINE (AKA EBI, LLC)
  SUBSTANTIALLY EQUIVALENT 2
CHOICE SPINE, LP
  SUBSTANTIALLY EQUIVALENT 1
CORELINK LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EBI, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH SARASOTA
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
GOLD STANDARD ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
INTELLIGENT IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON AND JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
K2M
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 7
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LANX, INC.
  SUBSTANTIALLY EQUIVALENT 6
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE, INC
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOAFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC SOFAMOR DANEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMNI SURGICAL LLC DBA SPINE360
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED L.P.
  SUBSTANTIALLY EQUIVALENT 1
PARADIGM SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
PIONEER SURGICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 2
PIONEER SURGICAL TECHNOLOGY, INC
  SUBSTANTIALLY EQUIVALENT 2
PIONEER SURGICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SOUTHERN SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL USA
  SUBSTANTIALLY EQUIVALENT 1
SPINECRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES (USA)
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES SPINE
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES USA PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES USA PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ULRICH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
VERTIFLEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 2
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1019 1019
2015 1348 1348
2016 1378 1378
2017 863 863
2018 657 657
2019 518 518
2020 796 796
2021 529 529
2022 336 336
2023 331 331
2024 179 179

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2230 2230
Failure to Align 1051 1051
Adverse Event Without Identified Device or Use Problem 957 957
Migration or Expulsion of Device 674 674
Device Slipped 587 587
Fracture 315 315
Loose or Intermittent Connection 297 297
Material Deformation 275 275
Device Dislodged or Dislocated 268 268
Migration 226 226
Loosening of Implant Not Related to Bone-Ingrowth 185 185
Appropriate Term/Code Not Available 146 146
Mechanical Problem 146 146
Material Integrity Problem 100 100
Device Operates Differently Than Expected 99 99
Metal Shedding Debris 95 95
Detachment Of Device Component 82 82
Detachment of Device or Device Component 76 76
Malposition of Device 76 76
Unintended Movement 67 67
Insufficient Information 63 63
Torn Material 59 59
Mechanical Jam 53 53
Device Appears to Trigger Rejection 46 46
Device Damaged by Another Device 44 44
Material Twisted/Bent 41 41
Device-Device Incompatibility 39 39
Bent 39 39
Difficult to Remove 37 37
Use of Device Problem 37 37
Mechanics Altered 35 35
No Apparent Adverse Event 35 35
Material Fragmentation 31 31
Device Inoperable 27 27
Disassembly 26 26
Peeled/Delaminated 22 22
Material Separation 21 21
Naturally Worn 21 21
Connection Problem 18 18
Positioning Problem 18 18
Patient-Device Incompatibility 17 17
Crack 17 17
Failure To Adhere Or Bond 17 17
Difficult to Insert 15 15
Noise, Audible 14 14
Packaging Problem 13 13
Entrapment of Device 13 13
Fitting Problem 11 11
Improper or Incorrect Procedure or Method 10 10
Failure to Advance 10 10
Unstable 10 10
Corroded 10 10
Biocompatibility 10 10
Material Erosion 9 9
Inadequacy of Device Shape and/or Size 8 8
Expulsion 8 8
Scratched Material 8 8
Compatibility Problem 7 7
Material Protrusion/Extrusion 7 7
Device Markings/Labelling Problem 7 7
Product Quality Problem 7 7
Defective Component 7 7
Disconnection 7 7
Collapse 6 6
Degraded 6 6
Patient Device Interaction Problem 6 6
Material Split, Cut or Torn 5 5
Device Operational Issue 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Difficult to Open or Close 5 5
Material Disintegration 5 5
Separation Failure 5 5
Material Too Rigid or Stiff 5 5
Difficult To Position 4 4
Sticking 4 4
Component Missing 4 4
Failure to Osseointegrate 4 4
Difficult to Advance 4 4
Defective Device 4 4
Device Handling Problem 4 4
Osseointegration Problem 4 4
Incomplete or Missing Packaging 3 3
Nonstandard Device 3 3
Shelf Life Exceeded 3 3
Component Falling 3 3
Contamination 3 3
Failure to Capture 3 3
Loss of or Failure to Bond 2 2
Positioning Failure 2 2
Flaked 2 2
Device Expiration Issue 2 2
Inadequate Instructions for Healthcare Professional 2 2
Leak/Splash 2 2
Unintended System Motion 2 2
Unsealed Device Packaging 2 2
Off-Label Use 2 2
Tear, Rip or Hole in Device Packaging 2 2
Out-Of-Box Failure 2 2
Therapeutic or Diagnostic Output Failure 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2846 2846
Pain 1179 1179
No Code Available 1107 1108
No Clinical Signs, Symptoms or Conditions 869 869
No Consequences Or Impact To Patient 531 531
Failure of Implant 368 368
No Information 297 297
Injury 244 244
Unspecified Infection 189 189
Device Embedded In Tissue or Plaque 144 144
Non-union Bone Fracture 139 139
Impaired Healing 111 111
Bone Fracture(s) 100 100
Discomfort 78 78
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 73 73
Seroma 71 71
Stenosis 69 69
Insufficient Information 65 65
Numbness 64 64
Neck Pain 63 63
Post Operative Wound Infection 62 62
Foreign Body In Patient 59 59
No Patient Involvement 52 52
Implant Pain 50 50
Spinal Column Injury 42 42
Reaction 38 38
Neuropathy 38 38
Ambulation Difficulties 38 38
Nerve Damage 36 36
Fall 36 36
Paralysis 34 34
Neurological Deficit/Dysfunction 32 32
Irritation 25 25
Patient Problem/Medical Problem 25 25
Weakness 24 24
Hypersensitivity/Allergic reaction 22 22
Not Applicable 21 21
Sedation 18 18
Spinal Cord Injury 18 18
Hematoma 17 17
Tingling 16 16
Hemorrhage/Bleeding 15 15
Joint Disorder 15 15
Osteolysis 14 14
Cerebrospinal Fluid Leakage 14 14
Inflammation 14 14
Ossification 14 14
Burning Sensation 13 13
Swelling 13 13
Dysphagia/ Odynophagia 13 13
Pressure Sores 13 13
Headache 12 12
Death 12 12
Unspecified Nervous System Problem 11 11
Joint Laxity 10 10
Disability 10 10
Inadequate Osseointegration 10 10
Muscle Weakness 10 10
Complaint, Ill-Defined 9 9
Muscle Spasm(s) 9 9
Loss of Range of Motion 8 8
Low Blood Pressure/ Hypotension 8 8
Blood Loss 8 8
Fever 8 8
Rash 8 8
Visual Disturbances 7 7
Purulent Discharge 7 7
Necrosis 7 7
Unspecified Tissue Injury 7 7
Foreign Body Reaction 6 6
Arthritis 6 6
Swelling/ Edema 6 6
Collapse 6 6
Inadequate Pain Relief 5 5
Paraplegia 5 5
Depression 5 5
Undesired Nerve Stimulation 5 5
Rupture 5 5
Abscess 5 5
Nausea 5 5
Anxiety 5 5
Pleural Effusion 5 5
Sepsis 5 5
Perforation of Esophagus 4 4
Unspecified Musculoskeletal problem 4 4
Laceration(s) 4 4
Pulmonary Embolism 4 4
Neck Stiffness 4 4
Cyst(s) 4 4
Increased Sensitivity 4 4
Wound Dehiscence 4 4
Hernia 4 4
Staphylococcus Aureus 4 4
Dizziness 4 4
Fistula 3 3
Cardiac Arrest 3 3
Vomiting 3 3
Shaking/Tremors 3 3
Thrombus 3 3
Toxicity 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Mar-18-2013
2 Alphatec Spine, Inc. II Nov-08-2012
3 Alphatec Spine, Inc. II Jan-31-2012
4 Alphatec Spine, Inc. II Dec-14-2009
5 Alphatec Spine, Inc. II Dec-07-2009
6 Biomet Spine, LLC II Sep-10-2015
7 Biomet, Inc. II May-26-2016
8 DePuy Spine, Inc. II Aug-14-2009
9 EBI, L.P. III Sep-22-2009
10 K2M, Inc II Mar-01-2022
11 K2M, Inc. II Jun-30-2022
12 Medacta Usa Inc II Jan-13-2017
13 Medicrea International II Mar-11-2020
14 Medicrea International II Jan-24-2020
15 Medtronic Sofamor Danek USA Inc II Apr-19-2023
16 Medtronic Sofamor Danek USA Inc II May-08-2020
17 Medtronic Sofamor Danek USA Inc II Aug-19-2011
18 Medtronic Sofamor Danek USA Inc II Jul-25-2011
19 Orthofix, Inc II Feb-28-2013
20 Orthofix, Inc. II Jan-28-2014
21 PIONEER SURGICAL TECHNOLOGY, INC. II Sep-03-2014
22 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-11-2018
23 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-20-2016
24 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II May-26-2016
25 SeaSpine, Inc II Sep-03-2009
26 SpineFrontier, Inc. II Nov-21-2012
27 Stryker Spine I Aug-22-2013
28 Zimmer Biomet Spine Inc. II Feb-22-2019
29 Zimmer Biomet, Inc. II Jun-05-2019
30 Zimmer Biomet, Inc. II Jan-09-2016
31 Zimmer Inc. II Oct-08-2010
32 Zimmer Inc. III Dec-14-2009
33 Zimmer Spine, Inc. II Feb-26-2016
34 Zimmer, Inc. II Dec-12-2014
35 ulrich medical USA Inc II Mar-02-2020
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