TPLC - Total Product Life Cycle

• Device: screw, fixation, bone
• Product Code: HWC
• Regulation Number: 888.3040
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
A.M. SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
AAP IMPLANTATE AG
	SUBSTANTIALLY EQUIVALENT	4
ACTIVORTHO, INC
	SUBSTANTIALLY EQUIVALENT	1
ACTIVORTHO, INC.
	SUBSTANTIALLY EQUIVALENT	1
ACUMED LLC
	SUBSTANTIALLY EQUIVALENT	4
ADVANCED INTERVENTIONAL TECHNOLOGY, LLC
	SUBSTANTIALLY EQUIVALENT	2
AESCULAP IMPLANT SYSTEM, INC.
	SUBSTANTIALLY EQUIVALENT	1
AGENT MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
AJU PHARM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
AMORCHEM HOLDINGS, INC.
	SUBSTANTIALLY EQUIVALENT	1
APOGEE ORTHOSOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	10
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	5
ARTHROCARE CORP.
	SUBSTANTIALLY EQUIVALENT	2
ARTHROSURFACE, INC.
	SUBSTANTIALLY EQUIVALENT	4
ASCENSION ORTHOPEDIC
	SUBSTANTIALLY EQUIVALENT	1
ASCENSION ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	2
ASCENSION ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ASCENT MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
AUXANO MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
AUXEIN MEDICAL PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	2
AVANTI ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
AZURMEDS INC.
	SUBSTANTIALLY EQUIVALENT	2
BESPA GLOBAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
BIEDERMANN MEDTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET INC
	SUBSTANTIALLY EQUIVALENT	2
BIOMET INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET MANUFACTURING CORP.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET MICROFIXATION
	SUBSTANTIALLY EQUIVALENT	1
BIOMET MICROFIXATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET TRAUMA
	SUBSTANTIALLY EQUIVALENT	1
BIOMET, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOPRO, INC.
	SUBSTANTIALLY EQUIVALENT	1
BONUTTI RESEARCH, INC.
	SUBSTANTIALLY EQUIVALENT	2
BRM EXTREMITIES
	SUBSTANTIALLY EQUIVALENT	1
BRM EXTREMITIES SRL
	SUBSTANTIALLY EQUIVALENT	1
CARTIVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
CAYENNE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
CHANGZHOU ORTHMAR MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHM SP. Z O.O.
	SUBSTANTIALLY EQUIVALENT	1
CITIEFFE
	SUBSTANTIALLY EQUIVALENT	1
COMPETITIVE ENGINEERING INC.
	SUBSTANTIALLY EQUIVALENT	1
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CONMED LINVATEC
	SUBSTANTIALLY EQUIVALENT	1
CROSSROADS EXTEMITY SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
CROSSROADS EXTREMITY SYSTEMS LLC
	SUBSTANTIALLY EQUIVALENT	1
CROSSROADS EXTREMITY SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	2
CURVAFIX, INC.
	SUBSTANTIALLY EQUIVALENT	2
DEPUY MITEK
	SUBSTANTIALLY EQUIVALENT	1
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
	SUBSTANTIALLY EQUIVALENT	4
DIAMOND ORTHOPEDIC, LLC
	SUBSTANTIALLY EQUIVALENT	1
DOUBLE MEDICAL TECHNOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	2
EMERGE MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
EPIC EXTREMITY, LLC
	SUBSTANTIALLY EQUIVALENT	2
EXSOMED CORP.
	SUBSTANTIALLY EQUIVALENT	1
EXSOMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EXSOMED HOLDING COMPANY, LLC
	SUBSTANTIALLY EQUIVALENT	1
EXSOMED HOLDINGS COMPANY, LLC
	SUBSTANTIALLY EQUIVALENT	1
EXSOMED, CORP.
	SUBSTANTIALLY EQUIVALENT	1
EXTREMITY MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	7
EXTREMITY MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	3
EXTREMITY MEDICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	4
FEET FOR LIFE PODIATRY CENTER
	SUBSTANTIALLY EQUIVALENT	1
FIELD ORTHOPAEDICS PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
FIELD ORTHOPAEDICS PTY. LTD.
	SUBSTANTIALLY EQUIVALENT	1
FIRST RAY LLC
	SUBSTANTIALLY EQUIVALENT	1
FLOW-FX, LLC
	SUBSTANTIALLY EQUIVALENT	1
FLOWER ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
FORMA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
FOURNITURES HOSPITALIERES INDUSTRIE
	SUBSTANTIALLY EQUIVALENT	4
FUSION ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	6
FXDEVICES
	SUBSTANTIALLY EQUIVALENT	1
GEBR. BRASSELER GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
GLW MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
GLW, INC.
	SUBSTANTIALLY EQUIVALENT	1
GM DOS REIS INDUSTRIA E COMERCIO LTDA
	SUBSTANTIALLY EQUIVALENT	1
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. DBA GRAMEDICA
	SUBSTANTIALLY EQUIVALENT	1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
GRAMERCY EXTREMITY ORTHOPEIDICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ICON ORTHOPAEDIC CONCEPTS DBA EDGE ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
ICONN ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
IN2BONES SAS
	SUBSTANTIALLY EQUIVALENT	6
IN2BONES USA, LLC
	SUBSTANTIALLY EQUIVALENT	2
INFIX MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
INION OY
	SUBSTANTIALLY EQUIVALENT	2
INNOVATE ORTHOPAEDICS LIMITED
	SUBSTANTIALLY EQUIVALENT	2
INNOVISION, INC.
	SUBSTANTIALLY EQUIVALENT	3
INSTRATEK, INC.
	SUBSTANTIALLY EQUIVALENT	2
INTELLIGENT IMPLANT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
INTELLIGENT ORTHOPAEDICS LTD
	SUBSTANTIALLY EQUIVALENT	1
INTERNAL FIXATION SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
JEIL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
JOHN RICCIO
	SUBSTANTIALLY EQUIVALENT	2
KLS MARTIN LP
	SUBSTANTIALLY EQUIVALENT	1
LAURA CATTABRIGA
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	3
LIFE SPINE, INC
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
MAXXION MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL, SA
	SUBSTANTIALLY EQUIVALENT	1
MEDARTIS AG
	SUBSTANTIALLY EQUIVALENT	4
MEDICAL DESIGN LLC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL FACETS
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTIRES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
MEDSHAPE INC
	SUBSTANTIALLY EQUIVALENT	1
MEDSHAPE SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	3
MEDSHAPE, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDSHAPE, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEMOMETAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
MERETE GMBH
	SUBSTANTIALLY EQUIVALENT	1
MERETE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	4
METASURG
	SUBSTANTIALLY EQUIVALENT	2
MIAMI DEVICE SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MICROWARE PRECISION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MTP SOLUTIONS LLC
	SUBSTANTIALLY EQUIVALENT	2
MX ORTHOPEDICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
NEOORTHO PRODUTOS ORTOPEDICOS S/A
	SUBSTANTIALLY EQUIVALENT	1
NEOSTEO
	SUBSTANTIALLY EQUIVALENT	4
NEWCLIP TECHNICS
	SUBSTANTIALLY EQUIVALENT	4
NEXTREMITY SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	9
NEXTREMITY SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	2
NORMED MEDIZIN-TECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	3
NORMED NEDIZIN TECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
NOVASTEP
	SUBSTANTIALLY EQUIVALENT	3
NVISION BIOMEDICAL TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	4
NVISION BIOMEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
OMNIA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHO SOLUTIONS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ORTHO SOLUTIONS UK LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ORTHOCIRCLE SPINE D.B.A. OC MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	1
ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM
	SUBSTANTIALLY EQUIVALENT	2
ORTHOFIX SRL
	SUBSTANTIALLY EQUIVALENT	2
ORTHOHELIX SURGICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPAEDIC IMPLANT COMPANY
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS, CORP
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPRO LLC
	SUBSTANTIALLY EQUIVALENT	2
OSSIO LTD.
	SUBSTANTIALLY EQUIVALENT	4
OSTEOCENTRIC EXTREMITIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
OSTEOCENTRIC TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	3
OSTEOCENTRIC TRAUMA
	SUBSTANTIALLY EQUIVALENT	1
OSTEOMED
	SUBSTANTIALLY EQUIVALENT	2
OSTEOMED CORP.
	SUBSTANTIALLY EQUIVALENT	1
OSTEOMED LLC
	SUBSTANTIALLY EQUIVALENT	2
OSTEOSPRING MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
OVERMED SRL.
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28
	SUBSTANTIALLY EQUIVALENT	2
PARAGON 28 INC.
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28, INC.
	SUBSTANTIALLY EQUIVALENT	5
PARCUS MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	5
PEGA MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
PHALANX INNOVATIONS
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	2
RADICLE ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
RELJA INNOVATIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
RENOVIS SURGICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
RESPONSIVE ARTHROSCOPY LLC
	SUBSTANTIALLY EQUIVALENT	2
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	1
RESTORE SURGICAL LLC DBA INSTRATEK
	SUBSTANTIALLY EQUIVALENT	2
RETROFIX SCREWS, LLC
	SUBSTANTIALLY EQUIVALENT	1
SAFETYFIX MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SCIENCE FOR BIOMATERIALS
	SUBSTANTIALLY EQUIVALENT	1
SIGN FRACTURE CARE INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
SIGNUS MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
SKELETAL DYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
SKELETAL DYNAMICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
SMALL BONE INNOVATIONS INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	5
SMV SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	4
SOLANA SURGICAL LLC
	SUBSTANTIALLY EQUIVALENT	2
SONOMA ORTHOPEDICS PRODUCTS, INC
	SUBSTANTIALLY EQUIVALENT	1
STABILIZ ORTHOPAEDICS INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	6
STRYKER TRAUMA AG
	SUBSTANTIALLY EQUIVALENT	3
STUCKENBROCK MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
SUBCHONDRAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
SUBCHONDRAL SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUMMIT MEDVENTURES
	SUBSTANTIALLY EQUIVALENT	1
SURGTECH INC
	SUBSTANTIALLY EQUIVALENT	1
SYNCHRO MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SYNERGY SURGICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
SYNOVIS ORTHOPEDIC & WOUNDCARE
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA)
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES (USA) PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES (USA) PRODUCTS LLC / DEPUY ORTHOPAEDICS INC
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES USA
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES USA PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	3
T.A.G. MEDICAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	2
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
	SUBSTANTIALLY EQUIVALENT	1
TARSUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
TDM CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
TDM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TORNIER, INC.
	SUBSTANTIALLY EQUIVALENT	1
TRAX SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
TREACE MEDICAL CONCEPTS, INC.
	SUBSTANTIALLY EQUIVALENT	4
TREU-INSTRUMENTE GMBH
	SUBSTANTIALLY EQUIVALENT	1
TRILLIANT SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
TRILLIANT SURGICAL LTD
	SUBSTANTIALLY EQUIVALENT	4
TRILLIANT SURGICAL, LTD
	SUBSTANTIALLY EQUIVALENT	1
TRIMED, INC
	SUBSTANTIALLY EQUIVALENT	1
TRIMED, INC.
	SUBSTANTIALLY EQUIVALENT	3
TYBER MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	6
TYBER MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
U&I CORP.
	SUBSTANTIALLY EQUIVALENT	1
U.S. IMPLANT SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
UNIVERSITY OF UTAH, DEPARTMENT OF ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
VILEX IN TENNESSEE, INC
	SUBSTANTIALLY EQUIVALENT	1
VILEX IN TENNESSEE, INC.
	SUBSTANTIALLY EQUIVALENT	2
VILEX LLC
	SUBSTANTIALLY EQUIVALENT	1
VILEX, LLC
	SUBSTANTIALLY EQUIVALENT	1
VOOM MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
WISHBONE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL TECHNOLOGY
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	22
Z-MEDICAL GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
ZIMED MEDIKAL
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	6

MDR Year	MDR Reports	MDR Events
2014	2539	2539
2015	2700	2700
2016	2282	2282
2017	2559	2559
2018	3658	3658
2019	5457	5461
2020	4816	4819
2021	4441	4504
2022	3933	4287
2023	3736	3736
2024	970	970

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	14260	14540
Break	9059	9133
Migration	1990	2049
Device-Device Incompatibility	1726	1726
Fracture	1362	1366
Insufficient Information	870	870
Migration or Expulsion of Device	812	812
Material Twisted/Bent	585	585
Material Fragmentation	543	543
Device Dislodged or Dislocated	515	526
Unintended Movement	511	511
Device Slipped	492	492
Appropriate Term/Code Not Available	486	486
No Apparent Adverse Event	462	462
Entrapment of Device	424	424
Device Operates Differently Than Expected	394	394
Difficult to Remove	331	331
Detachment of Device or Device Component	270	270
Material Deformation	256	256
Loose or Intermittent Connection	254	254
Positioning Failure	230	230
Loss of Osseointegration	227	227
Patient Device Interaction Problem	224	224
Material Separation	213	213
Manufacturing, Packaging or Shipping Problem	194	194
Patient-Device Incompatibility	193	193
Loosening of Implant Not Related to Bone-Ingrowth	176	176
Malposition of Device	166	166
Detachment Of Device Component	155	155
Difficult to Advance	146	146
Use of Device Problem	143	143
Corroded	140	140
Crack	134	134
Difficult to Insert	130	130
Fitting Problem	130	130
Improper or Incorrect Procedure or Method	106	106
Mechanical Jam	106	106
Mechanical Problem	105	105
Failure to Align	104	104
Bent	102	102
Material Integrity Problem	101	101
Failure To Adhere Or Bond	85	85
Positioning Problem	80	80
Failure to Advance	77	77
Unknown (for use when the device problem is not known)	72	72
Unstable	59	59
Inadequacy of Device Shape and/or Size	56	56
Packaging Problem	56	56
Material Protrusion/Extrusion	54	54
Component Missing	52	52
Osseointegration Problem	48	48
Defective Device	47	47
Failure to Osseointegrate	46	46
Metal Shedding Debris	43	43
Sticking	43	43
Dull, Blunt	43	43
Device Markings/Labelling Problem	42	42
Physical Resistance/Sticking	41	41
Material Split, Cut or Torn	37	37
Noise, Audible	37	37
Naturally Worn	36	36
Compatibility Problem	34	34
Separation Failure	34	34
Material Frayed	33	33
Loss of or Failure to Bond	32	32
Tear, Rip or Hole in Device Packaging	27	27
Peeled/Delaminated	26	26
Device Contaminated During Manufacture or Shipping	26	26
Mechanics Altered	26	26
Activation, Positioning or Separation Problem	25	25
Device Damaged by Another Device	23	23
Biocompatibility	23	23
Device Damaged Prior to Use	23	23
Therapeutic or Diagnostic Output Failure	23	23
Device Contamination with Chemical or Other Material	23	23
Degraded	22	22
Material Erosion	22	22
Material Discolored	20	20
Off-Label Use	20	20
Device Expiration Issue	19	19
Component Incompatible	19	19
Contamination /Decontamination Problem	19	19
Failure to Cut	19	19
Incomplete or Missing Packaging	17	17
Difficult To Position	17	17
Component Falling	16	16
Unraveled Material	15	15
Component or Accessory Incompatibility	14	14
Delivered as Unsterile Product	14	14
Nonstandard Device	13	13
Collapse	13	13
Material Disintegration	13	13
Deformation Due to Compressive Stress	13	13
Defective Component	13	13
Residue After Decontamination	12	12
Connection Problem	12	12
Flaked	12	12
Inaccurate Information	12	12
Device Difficult to Maintain	12	12
Device Handling Problem	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	6787	6787
Pain	4790	4792
Non-union Bone Fracture	4485	4629
No Clinical Signs, Symptoms or Conditions	3977	4057
Unspecified Infection	3598	3599
Failure of Implant	3423	3439
No Known Impact Or Consequence To Patient	3099	3106
No Consequences Or Impact To Patient	1697	1697
Bone Fracture(s)	1347	1361
Insufficient Information	1309	1338
Impaired Healing	1128	1128
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	999	999
No Information	997	997
Foreign Body In Patient	972	978
Device Embedded In Tissue or Plaque	963	963
Injury	875	875
Discomfort	740	740
Post Operative Wound Infection	593	593
Loss of Range of Motion	487	487
Necrosis	484	539
Hypersensitivity/Allergic reaction	398	398
Reaction	385	385
Unspecified Tissue Injury	321	321
Swelling	317	317
Nerve Damage	270	270
No Patient Involvement	264	264
Not Applicable	263	263
Irritation	252	252
Implant Pain	224	246
Inflammation	213	213
Malunion of Bone	189	212
Sedation	188	188
Physical Asymmetry	184	184
Tissue Damage	183	183
Wound Dehiscence	183	183
Arthritis	180	184
Skin Inflammation/ Irritation	174	174
Swelling/ Edema	156	156
Fall	151	151
Osteolysis	141	142
Inadequate Osseointegration	133	133
Hematoma	132	132
Numbness	106	106
Ossification	105	105
Rash	102	102
Limited Mobility Of The Implanted Joint	97	97
Ambulation Difficulties	95	95
Joint Dislocation	95	95
Foreign Body Reaction	88	88
Dysphagia/ Odynophagia	84	84
Hip Fracture	81	81
Deformity/ Disfigurement	78	79
Muscle/Tendon Damage	75	75
Skin Irritation	72	72
Bacterial Infection	70	70
Muscular Rigidity	68	68
Scar Tissue	67	67
Rupture	61	61
Patient Problem/Medical Problem	60	60
Neurological Deficit/Dysfunction	59	59
Paralysis	59	59
Death	55	55
Abscess	54	54
Erythema	52	52
Fatigue	47	47
Fistula	47	47
Spinal Column Injury	45	45
Limb Fracture	45	62
Purulent Discharge	43	43
Adhesion(s)	43	43
Neuropathy	40	40
Ulcer	40	44
Unspecified Nervous System Problem	37	37
Calcium Deposits/Calcification	37	37
Cyst(s)	37	37
Headache	36	36
Metal Related Pathology	35	35
Weakness	33	33
Fluid Discharge	32	32
Hypoesthesia	32	32
Synovitis	31	31
Perforation	31	31
Itching Sensation	30	30
Erosion	30	30
Unknown (for use when the patient's condition is not known)	30	30
Joint Disorder	30	30
Hemorrhage/Bleeding	29	29
Thrombosis	29	29
Joint Laxity	28	28
Staphylococcus Aureus	27	27
Emotional Changes	27	27
Sepsis	26	26
Difficulty Chewing	25	25
Osteopenia/ Osteoporosis	25	25
Blood Loss	24	24
Sleep Dysfunction	24	24
Toxicity	24	24
Cerebrospinal Fluid Leakage	23	23
Thrombosis/Thrombus	22	22
Fever	21	21

Recalls
Manufacturer		Recall Class	Date Posted
1	Acumed LLC	II	Dec-23-2022
2	Acumed LLC	II	Apr-20-2022
3	Acumed LLC	II	May-14-2010
4	Acumed LLC	II	Oct-23-2009
5	Arthrex, Inc.	II	Mar-17-2020
6	Biomet	II	Jun-09-2020
7	Biomet Microfixation, Inc.	II	Jul-22-2011
8	Biomet Microfixation, Inc.	II	Jan-04-2010
9	Biomet, Inc.	II	Dec-17-2020
10	Biomet, Inc.	II	May-26-2016
11	Biomet, Inc.	II	Jul-01-2015
12	Biomet, Inc.	II	Jan-30-2013
13	Biomet, Inc.	II	Mar-21-2012
14	Biomet, Inc.	II	Mar-09-2011
15	Biomet, Inc.	II	Feb-02-2010
16	Biomet, Inc.	II	Jan-13-2010
17	Biomet, Inc.	II	Nov-12-2009
18	Cayenne Medical Inc.	II	Jul-10-2018
19	CrossRoads Extremity Systems, LLC	II	Oct-24-2019
20	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	Jun-20-2017
21	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	Oct-25-2012
22	Ebi, Llc	II	Nov-19-2013
23	Encore Medical, Lp	II	Oct-25-2012
24	Encore Medical, Lp	II	Aug-06-2012
25	Extremity Medical LLC	II	Jan-30-2013
26	Extremity Medical LLC	II	Nov-18-2012
27	Flower Orthopedics Corporation	II	Mar-24-2015
28	In2Bones, SAS	II	Mar-20-2024
29	In2Bones, SAS	II	Dec-09-2015
30	In2Bones, SAS	II	Mar-25-2015
31	In2bones USA, LLC	II	Aug-21-2018
32	Innovatech Medical Resources L.P.	II	Jan-11-2012
33	Instratek, Incorporated	II	Sep-22-2014
34	Integra LifeSciences Corp.	II	Aug-19-2016
35	Integra LifeSciences Corporation	II	Jun-02-2014
36	Integra LifeSciences Corporation	II	Apr-07-2010
37	Integra Limited	II	Apr-05-2019
38	Medartis, Inc.	II	Oct-30-2014
39	Medshape, INC.	II	Jan-04-2022
40	MicroAire Surgical Instruments, LLC	II	Jul-27-2016
41	MicroPort Orthopedics Inc.	II	Oct-11-2018
42	Nextremity Solutions	II	Apr-12-2022
43	Nextremity Solutions	II	Mar-09-2022
44	Nextremity Solutions	II	Apr-27-2021
45	Nextremity Solutions	II	Feb-24-2020
46	Nextremity Solutions	II	Jan-03-2020
47	ORTHO SOLUTIONS, LTD.	II	Mar-09-2018
48	Ortho Solutions Inc	II	Sep-16-2016
49	Ortho Solutions Inc	II	Oct-06-2015
50	OrthoPediatrics Corp	II	Sep-19-2016
51	OrthoPediatrics Corp	II	Feb-06-2014
52	OrthoPediatrics Corp	II	Aug-09-2013
53	OrthoPediatrics Corp	II	Jun-12-2013
54	Orthohelix Surgical Designs Inc	II	Oct-09-2012
55	Orthohelix Surgical Designs Inc	II	Jun-10-2010
56	Orthohelix Surgical Designs Inc	II	Apr-06-2010
57	Orthopedic Alliance LLC	II	May-24-2013
58	PROVIDENCE MEDICAL TECHNOLOGIES	II	Jun-25-2020
59	Pega Medical Inc.	II	Nov-20-2015
60	Pega Medical Inc.	II	Jun-26-2015
61	SCIENCE & BIO MATERIALS	II	Jul-08-2022
62	Small Bone Innovations	II	Jul-30-2014
63	Smith & Nephew, Inc.	II	Oct-19-2021
64	Smith & Nephew, Inc.	II	Mar-20-2018
65	Smith & Nephew, Inc.	II	Apr-18-2017
66	Smith & Nephew, Inc. Endoscopy Division	II	Sep-17-2013
67	Smith & Nephew, Inc. Endoscopy Division	II	Mar-19-2012
68	Stryker Corporation	II	Mar-02-2018
69	Stryker Craniomaxillofacial Division	II	May-07-2010
70	Stryker Endoscopy	II	Dec-14-2010
71	Stryker Howmedica Osteonics Corp.	II	Apr-18-2016
72	Stryker Howmedica Osteonics Corp.	II	Dec-11-2013
73	Stryker Howmedica Osteonics Corp.	II	Aug-27-2013
74	Stryker Howmedica Osteonics Corp.	II	Nov-19-2012
75	Stryker Howmedica Osteonics Corp.	III	Sep-14-2009
76	Synthes (USA) Products LLC	II	Oct-24-2018
77	Synthes (USA) Products LLC	II	Jul-11-2016
78	Synthes (USA) Products LLC	II	Apr-27-2016
79	Synthes (USA) Products LLC	II	Nov-20-2015
80	Synthes (USA) Products LLC	II	Sep-18-2015
81	Synthes USA HQ, Inc.	II	Nov-26-2013
82	Synthes USA HQ, Inc.	II	Oct-17-2013
83	Synthes USA HQ, Inc.	II	Mar-28-2013
84	Synthes, Inc.	II	Jun-15-2015
85	Synthes, Inc.	II	Aug-19-2014
86	Synthes, Inc.	II	Jul-02-2014
87	Trilliant Surgical LTD	II	Apr-26-2010
88	Trilliant Surgical Ltd.	II	Jan-06-2017
89	Trilliant Surgical Ltd.	II	Nov-17-2016
90	Trilliant Surgical Ltd.	II	Aug-26-2015
91	Trilliant Surgical Ltd.	II	Aug-19-2015
92	Trilliant Surgical, LLC	II	Mar-30-2020
93	Wright Medical Technology Inc	II	Jun-17-2011
94	Wright Medical Technology, Inc.	II	Nov-25-2019
95	Wright Medical Technology, Inc.	II	May-18-2015
96	Zimmer Biomet, Inc.	II	Nov-07-2019
97	Zimmer Biomet, Inc.	II	May-09-2019
98	Zimmer Biomet, Inc.	II	Sep-14-2018
99	Zimmer Biomet, Inc.	II	May-08-2018
100	Zimmer Biomet, Inc.	II	Mar-15-2018