TPLC - Total Product Life Cycle

• Device: plate, fixation, bone
• Product Code: HRS
• Regulation Number: 888.3030
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
4WEB MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
A PLUS BIOTECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
AAP IMPLANTATE AG
	SUBSTANTIALLY EQUIVALENT	5
ACUMED LLC
	SUBSTANTIALLY EQUIVALENT	1
ADDITIVE ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	12
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	1
AUXEIN MEDICAL PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	4
AVANTI ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET MICOFIXATION
	SUBSTANTIALLY EQUIVALENT	2
BIOMET MICROFIXATION
	SUBSTANTIALLY EQUIVALENT	3
BODYCAD LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
BONEBRIDGE AG
	SUBSTANTIALLY EQUIVALENT	3
CARBOFIX ORTHOPEDICS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CROSSROADS EXTEMITY SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
CROSSROADS EXTREMITY SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
CROSSROADS EXTREMITY SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	3
DEPUY SYNTHES
	SUBSTANTIALLY EQUIVALENT	8
DOUBLE MEDICAL TECHNOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	2
ENDEAVOR ORTHOPAEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
EPIC EXTREMITY, LLC
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC
	SUBSTANTIALLY EQUIVALENT	1
EXREMITY MEDICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	1
EXSOMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EXTREMITY MEDICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	2
FIELD ORTHOPAEDICS PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
FIXIER, S.A. DE C.V.
	SUBSTANTIALLY EQUIVALENT	1
FUSION INNOVATIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
FUSION ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
FUSION ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	3
GLW MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
GM DOS REIS INDUSTRIA E COMERCIO LTDA
	SUBSTANTIALLY EQUIVALENT	2
GM DOS REIS INDUSTRIA E COMERICO LTDA.
	SUBSTANTIALLY EQUIVALENT	1
GPC MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	3
HANKIL TECH MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HOSPITAL EQUIPMENT MANUFACTURING COMPANY
	SUBSTANTIALLY EQUIVALENT	1
I.T.S. GMBH
	SUBSTANTIALLY EQUIVALENT	1
IN2BONES USA, LLC
	SUBSTANTIALLY EQUIVALENT	9
INDUSTRIAS MEDICAS SAMPEDRO S.A.S
	SUBSTANTIALLY EQUIVALENT	1
INTAI TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INTRAUMA S.P.A
	SUBSTANTIALLY EQUIVALENT	1
JACE MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
JEIL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	9
JIANGSU TRAUHUI MEDICAL INSTRUMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
JM LONGYEAR MANUFACTURING, LLC D.B.A. ABLE MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	1
JM LONGYEAR MANUFACTURING, LLC D/B/A ABLE MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	2
KLS MARTIN L.P.
	SUBSTANTIALLY EQUIVALENT	1
KLS-MARTIN L.P.
	SUBSTANTIALLY EQUIVALENT	2
LEITH MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
MAXXION MEDICAL, LLC / BAUMER SA
	SUBSTANTIALLY EQUIVALENT	1
MCGINLEY ORTHPAEDIC INNOVATIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDARTIS AG
	SUBSTANTIALLY EQUIVALENT	10
MEDLINE INDUSTIRES, LP
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	2
MICROWARE PRECISION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	2
NEBULA SURGICAL PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
NEOSTEO
	SUBSTANTIALLY EQUIVALENT	1
NEWCLIP TECHNICS
	SUBSTANTIALLY EQUIVALENT	4
NEXTREMITY SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	3
NOVASTEP
	SUBSTANTIALLY EQUIVALENT	1
NVISION BIOMEDICAL TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	2
ORTHO SOLUTIONS UK LTD
	SUBSTANTIALLY EQUIVALENT	2
ORTHOFIX SRL
	SUBSTANTIALLY EQUIVALENT	3
ORTHOPAEDIC IMPLANT COMPANY
	SUBSTANTIALLY EQUIVALENT	3
ORTHOPEDIATRICS, CORP
	SUBSTANTIALLY EQUIVALENT	1
OSTEOMED
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28, INC.
	SUBSTANTIALLY EQUIVALENT	4
PIONEER SURGICAL TECHNOLOGY, INC D.B.A RESOLVE SURGICAL TECH
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
S H PITKAR ORTHOTOOLS PVT LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIG MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SKELETAL DYNAMICS INC
	SUBSTANTIALLY EQUIVALENT	1
SKELETAL DYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	5
SKY SURGICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	5
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	10
SYNTHES (USA) PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES (USA) PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	3
TDM CO. LTD.
	SUBSTANTIALLY EQUIVALENT	2
TDM CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TECHFIT DIGITAL SURGERY INC.
	SUBSTANTIALLY EQUIVALENT	1
TORNIER INC.
	SUBSTANTIALLY EQUIVALENT	1
TREACE MEDICAL CONCEPTS INC.
	SUBSTANTIALLY EQUIVALENT	2
TREACE MEDICAL CONCEPTS, INC.
	SUBSTANTIALLY EQUIVALENT	4
TRILLIANT SURGICAL
	SUBSTANTIALLY EQUIVALENT	2
TRIMED, INC.
	SUBSTANTIALLY EQUIVALENT	3
TRUEMED GROUP LLC
	SUBSTANTIALLY EQUIVALENT	2
TYBER MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	2
TYBER MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
TYBER MEDICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	4
VILEX LLC
	SUBSTANTIALLY EQUIVALENT	3
WISHBONE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	3
ZIMMER GMBH
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	3356	3356
2020	2790	2790
2021	2443	2443
2022	1700	1703
2023	2058	2058
2024	524	524

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	6152	6154
Break	2096	2098
Fracture	993	995
Device-Device Incompatibility	641	641
Migration	546	546
Insufficient Information	274	274
Appropriate Term/Code Not Available	235	235
No Apparent Adverse Event	209	209
Material Twisted/Bent	204	204
Migration or Expulsion of Device	147	147
Loosening of Implant Not Related to Bone-Ingrowth	143	143
Material Deformation	131	131
Device Slipped	122	122
Patient Device Interaction Problem	107	107
Use of Device Problem	105	105
Positioning Failure	98	98
Device Dislodged or Dislocated	96	96
Detachment of Device or Device Component	77	77
Patient-Device Incompatibility	74	74
Material Fragmentation	64	64
Delivered as Unsterile Product	60	60
Entrapment of Device	57	57
Defective Device	56	56
Corroded	53	53
Unintended Movement	50	50
Manufacturing, Packaging or Shipping Problem	47	47
Osseointegration Problem	46	46
Physical Resistance/Sticking	45	45
Difficult to Remove	44	44
Loose or Intermittent Connection	43	43
Off-Label Use	41	41
Packaging Problem	39	39
Tear, Rip or Hole in Device Packaging	38	38
Difficult to Insert	37	37
Mechanical Problem	36	36
Inadequacy of Device Shape and/or Size	36	36
Material Integrity Problem	34	34
Malposition of Device	31	31
Crack	28	28
Improper or Incorrect Procedure or Method	27	27
Connection Problem	27	27
Positioning Problem	27	27
Unstable	25	25
Device Contaminated During Manufacture or Shipping	21	21
Naturally Worn	19	19
Loss of or Failure to Bond	19	19
Fitting Problem	18	18
Inaccurate Information	18	18
Unsealed Device Packaging	16	16
Noise, Audible	15	15
Contamination /Decontamination Problem	15	15
Separation Problem	14	14
Failure to Osseointegrate	14	14
Loss of Osseointegration	13	13
Device Markings/Labelling Problem	13	13
Device Appears to Trigger Rejection	12	12
Dull, Blunt	11	11
Incomplete or Inadequate Connection	11	11
Therapeutic or Diagnostic Output Failure	11	11
Material Separation	10	10
Failure to Advance	9	9
Difficult to Advance	9	9
Mechanical Jam	9	9
Device Damaged by Another Device	8	8
Failure to Align	8	8
Component Missing	8	8
Material Discolored	7	7
Failure to Cut	7	7
Material Protrusion/Extrusion	7	7
Output Problem	7	7
Deformation Due to Compressive Stress	6	6
Device Difficult to Maintain	6	6
Nonstandard Device	6	6
Device Difficult to Setup or Prepare	5	5
Unexpected Therapeutic Results	5	5
Flaked	5	5
Contamination	4	4
Degraded	4	4
Difficult or Delayed Positioning	4	4
Defective Component	4	4
Device Handling Problem	4	4
Difficult or Delayed Separation	4	4
Biocompatibility	4	4
Blocked Connection	4	4
Calibration Problem	3	3
Material Split, Cut or Torn	3	3
Shipping Damage or Problem	3	3
Material Rupture	3	3
Unintended System Motion	3	3
Material Erosion	3	3
Incorrect Measurement	3	3
Material Frayed	2	2
Particulates	2	2
Misconnection	2	2
Collapse	2	2
Signal Artifact/Noise	2	2
Overheating of Device	2	2
Material Puncture/Hole	2	2
Smoking	2	2
Problem with Sterilization	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	2087	2087
Non-union Bone Fracture	1674	1675
No Clinical Signs, Symptoms or Conditions	1651	1651
Pain	1580	1580
Failure of Implant	1362	1364
Unspecified Infection	1127	1127
Bone Fracture(s)	734	735
Insufficient Information	680	680
Injury	493	493
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	436	436
No Known Impact Or Consequence To Patient	419	419
Impaired Healing	396	396
Loss of Range of Motion	386	386
Discomfort	370	370
No Consequences Or Impact To Patient	347	347
Post Operative Wound Infection	334	334
Necrosis	311	311
Nerve Damage	234	234
Foreign Body In Patient	232	232
No Information	195	195
Implant Pain	194	194
Skin Inflammation/ Irritation	171	171
Malunion of Bone	169	169
Physical Asymmetry	169	169
Arthritis	146	146
Wound Dehiscence	144	144
Hypersensitivity/Allergic reaction	128	128
Swelling/ Edema	117	117
No Patient Involvement	110	110
Device Embedded In Tissue or Plaque	104	104
Unspecified Tissue Injury	99	99
Muscle/Tendon Damage	70	70
Swelling	69	69
Muscular Rigidity	67	67
Osteolysis	66	66
Hematoma	60	60
Fall	58	58
Deformity/ Disfigurement	56	56
Reaction	54	54
Irritation	53	53
Skin Irritation	51	51
Inflammation	50	50
Joint Dislocation	49	49
Hypoesthesia	48	48
Dysphagia/ Odynophagia	48	48
Tissue Damage	41	41
Ossification	39	39
Unspecified Musculoskeletal problem	36	36
Hemorrhage/Bleeding	35	36
Numbness	35	35
Osteopenia/ Osteoporosis	31	31
Scar Tissue	30	30
Calcium Deposits/Calcification	28	28
Bacterial Infection	26	26
Adhesion(s)	25	25
Pneumothorax	24	24
Fluid Discharge	23	23
Metal Related Pathology	23	23
Ambulation Difficulties	22	22
Patient Problem/Medical Problem	21	21
Cerebrospinal Fluid Leakage	21	21
Rash	20	20
Neuropathy	20	20
Perforation	19	19
Fistula	19	19
Thrombosis/Thrombus	19	19
Inadequate Osseointegration	18	18
Sepsis	18	18
Rupture	18	18
Abscess	16	16
Joint Disorder	15	15
Limb Fracture	15	15
Decreased Sensitivity	14	14
Visual Impairment	14	14
Weakness	13	13
Thrombosis	13	13
Foreign Body Reaction	13	13
Fatigue	13	13
Blood Loss	13	13
Limited Mobility Of The Implanted Joint	12	12
Paralysis	12	12
Pneumonia	12	12
Burning Sensation	12	12
Tingling	12	12
Pocket Erosion	11	11
Itching Sensation	11	11
Pulmonary Embolism	11	11
Joint Contracture	11	11
Skin Infection	11	11
Edema	10	10
Death	10	10
Eye Injury	10	10
Visual Disturbances	10	10
Local Reaction	9	9
Cyst(s)	9	9
Dyspnea	9	9
Cellulitis	9	9
Erosion	8	8
Erythema	8	8
Headache	8	8

Recalls
Manufacturer		Recall Class	Date Posted
1	Acumed LLC	II	Feb-29-2024
2	Arthrex, Inc.	II	Apr-09-2021
3	Arthrex, Inc.	II	Jul-29-2020
4	Biomet	II	Jun-09-2020
5	Biomet, Inc.	II	Jan-21-2021
6	Flower Orthopedics Corporation	II	Oct-06-2021
7	Flower Orthopedics Corporation	II	Aug-12-2020
8	GRAMERCY EXTREMITY ORTHOPEDICS	II	Apr-17-2023
9	I.T.S. GmbH	II	Jun-04-2019
10	K2M, Inc	II	Apr-12-2021
11	Miami Device Solutions, LLC.	II	Dec-05-2019
12	Nextremity Solutions	II	Feb-11-2020
13	Nextremity Solutions	II	Nov-22-2019
14	Paragon 28, Inc.	II	Jul-25-2022
15	Smith & Nephew, Inc.	II	Feb-01-2022
16	Smith & Nephew, Inc.	II	Dec-10-2021
17	Smith & Nephew, Inc.	II	Nov-18-2021
18	Smith & Nephew, Inc.	II	Sep-09-2020
19	Stryker GmbH	II	Jan-07-2020
20	Synthes (USA) Products LLC	II	Mar-01-2024
21	Synthes (USA) Products LLC	II	Aug-17-2020
22	Synthes, Inc.	II	Jan-29-2020
23	Toby Orthopaedics, Inc.	II	Dec-04-2019
24	TriMed Inc.	II	Jan-31-2024
25	TriMed Inc.	II	Nov-13-2019
26	TriMed Inc.	II	Oct-10-2019
27	TriMed Inc.	II	Apr-23-2019
28	Wishbone Medical, Inc.	II	Jun-04-2021
29	Wright Medical Technology Inc	II	Dec-17-2021
30	Wright Medical Technology, Inc.	II	Apr-26-2023
31	Wright Medical Technology, Inc.	II	Feb-24-2023
32	Wright Medical Technology, Inc.	II	Mar-15-2022
33	Wright Medical Technology, Inc.	II	Feb-25-2022
34	Wright Medical Technology, Inc.	II	Dec-20-2021
35	Wright Medical Technology, Inc.	II	Nov-25-2019
36	Zimmer Biomet, Inc.	II	Nov-07-2019
37	Zimmer, Inc.	II	Jul-28-2023