TPLC - Total Product Life Cycle

• Device: orthopedic stereotaxic instrument
• Definition: Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
• Product Code: OLO
• Regulation Number: 882.4560
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
7D SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
7D SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	5
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
AUGMEDICS LTD
	SUBSTANTIALLY EQUIVALENT	1
AUGMEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
BLUE BELT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	9
BLUE ORTHO
	SUBSTANTIALLY EQUIVALENT	5
BRAINLAB AG
	SUBSTANTIALLY EQUIVALENT	8
CAMBER SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE, LP.
	SUBSTANTIALLY EQUIVALENT	1
CHOICESPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
CLARIANCE, SAS
	SUBSTANTIALLY EQUIVALENT	1
CORELINK LLC
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	3
CORIN LTD.
	SUBSTANTIALLY EQUIVALENT	1
CORIN USA
	SUBSTANTIALLY EQUIVALENT	1
CTL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CUREXO, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	1
ECENTIAL ROBOTICS
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	6
INSIGHT MEDICAL SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	1
INTAI TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INTEGRITY IMPLANTS INC.
	SUBSTANTIALLY EQUIVALENT	1
INTELLIJOINT SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	4
IZI MEDICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
K2M
	SUBSTANTIALLY EQUIVALENT	3
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	2
KICO KNEE INNOVATION COMPANY PTY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1
MAKO SURGICAL CORP.
	SUBSTANTIALLY EQUIVALENT	10
MAZOR ROBOTICS LTD.
	SUBSTANTIALLY EQUIVALENT	6
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL, SA
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	4
MEDTECH S.A.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC NAVIGATION
	SUBSTANTIALLY EQUIVALENT	6
MEDTRONIC NAVIGATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC POWERED SURGICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC POWERED SURGICAL SOLUTIONS (MPSS)
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	8
MEDTRONIC SOFAMOR DANEK, USA INC
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT NAVIBOT INTERNATIONAL LLC
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	1
NAVBIT PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
NAVISWISS AG
	SUBSTANTIALLY EQUIVALENT	1
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
NOVARAD CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	4
OMNLLIFE SCIENCE INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHALIGN INC
	SUBSTANTIALLY EQUIVALENT	1
ORTHALIGN, INC.
	SUBSTANTIALLY EQUIVALENT	5
ORTHOFIX INC.
	SUBSTANTIALLY EQUIVALENT	2
ORTHOKEY ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS, CORP.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSOFT D/B/A ZIMMER CAS
	SUBSTANTIALLY EQUIVALENT	2
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	2
ORTHOSOFT, INC (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	1
ORTOMA AB
	SUBSTANTIALLY EQUIVALENT	1
OSSEUS FUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIXEE MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
POINT ROBOTICS MEDTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
PRACTICAL NAVIGATION, LLC
	SUBSTANTIALLY EQUIVALENT	1
PRECISION SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
PREMIA SPINE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
REMEX MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
REPUBLIC SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SI-BONE, INC.
	SUBSTANTIALLY EQUIVALENT	2
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	3
SPINAL ELEMENTS INC
	SUBSTANTIALLY EQUIVALENT	1
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINEART
	SUBSTANTIALLY EQUIVALENT	1
SPINEART SA
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	3
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	3
STRYKER LEIBINGER GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	1
SURGALIGN SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL THEATER, INC.
	SUBSTANTIALLY EQUIVALENT	1
THINK SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
THINK SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5
ULRICH MEDICAL USA
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
ZIMVIE (ZIMMER BIOMET SPINE, INC.)
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2017	1075	1075
2018	1233	1233
2019	1585	1585
2020	2744	2744
2021	1699	1699
2022	1164	1170

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	1156	1156
Break	1106	1106
Mechanical Problem	1014	1014
Insufficient Information	702	702
Non Reproducible Results	437	437
Fracture	435	435
Use of Device Problem	416	416
Computer Software Problem	415	415
Detachment of Device or Device Component	350	350
Material Deformation	344	344
Unintended Application Program Shut Down	325	325
Imprecision	302	302
Application Program Problem: Parameter Calculation Error	295	295
Adverse Event Without Identified Device or Use Problem	284	284
Connection Problem	276	276
Output Problem	247	247
Material Twisted/Bent	166	166
Incorrect, Inadequate or Imprecise Resultor Readings	162	162
Physical Resistance/Sticking	153	153
Application Program Problem	147	147
Unintended Movement	130	130
Defective Component	128	128
Mechanical Jam	126	126
Device Operates Differently Than Expected	116	116
Solder Joint Fracture	110	110
Residue After Decontamination	105	105
Display or Visual Feedback Problem	103	103
Device Slipped	99	99
Overheating of Device	90	90
Mechanics Altered	83	83
Positioning Problem	79	79
Loose or Intermittent Connection	78	78
Positioning Failure	74	74
Disassembly	73	73
Failure to Calibrate	70	70
Device-Device Incompatibility	68	68
Failure to Recalibrate	62	62
Intermittent Communication Failure	60	60
Electrical /Electronic Property Problem	59	59
Appropriate Term/Code Not Available	57	57
Material Frayed	56	56
Circuit Failure	55	55
Image Display Error/Artifact	53	53
Noise, Audible	50	50
Device Sensing Problem	46	46
Application Program Freezes, Becomes Nonfunctional	42	42
Bent	40	40
Communication or Transmission Problem	38	38
Difficult to Insert	38	38
No Apparent Adverse Event	38	38
Device Displays Incorrect Message	35	35
Calibration Problem	34	34
Defective Device	32	32
Computer Operating System Problem	32	32
Crack	30	30
Malposition of Device	29	29
Failure to Power Up	29	29
Difficult to Remove	28	28
Inappropriate Tactile Prompt/Feedback	28	28
Improper or Incorrect Procedure or Method	28	28
Electrical Power Problem	27	27
Deformation Due to Compressive Stress	27	27
Complete Loss of Power	26	26
Premature Separation	26	26
Device Operational Issue	26	26
Contamination /Decontamination Problem	25	25
Incorrect Measurement	25	25
Material Fragmentation	24	24
Naturally Worn	23	23
Entrapment of Device	23	23
No Display/Image	22	22
Suction Problem	22	22
Contamination of Device Ingredient or Reagent	22	22
Intermittent Loss of Power	21	21
Difficult or Delayed Positioning	21	21
Device Dislodged or Dislocated	20	20
Unstable	20	20
Inadequacy of Device Shape and/or Size	18	18
Material Split, Cut or Torn	17	17
Image Orientation Incorrect	17	17
Retraction Problem	16	16
Electrical Shorting	16	16
Power Problem	16	16
Operating System Becomes Nonfunctional	16	16
Degraded	15	15
Fluid Leak	15	15
Sharp Edges	15	15
Battery Problem	14	14
Loss of Osseointegration	13	13
Contamination	13	13
Separation Failure	13	13
Migration or Expulsion of Device	12	12
Fitting Problem	12	12
Separation Problem	11	11
Device Difficult to Setup or Prepare	10	10
Unintended System Motion	10	10
Off-Label Use	10	10
Material Separation	10	10
Interrogation Problem	9	9
Nonstandard Device	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	3483	3483
No Clinical Signs, Symptoms or Conditions	3101	3107
No Patient Involvement	1341	1341
No Consequences Or Impact To Patient	941	941
Injury	326	326
Pain	128	128
Foreign Body In Patient	120	120
Insufficient Information	81	81
Bone Fracture(s)	79	79
No Code Available	67	67
Unspecified Tissue Injury	64	64
No Information	61	61
Tissue Damage	59	59
Unspecified Infection	50	50
Device Embedded In Tissue or Plaque	42	42
Discomfort	41	41
Failure of Implant	20	20
Iatrogenic Source	18	18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	18
Joint Laxity	18	18
Inadequate Osseointegration	17	17
Laceration(s)	16	16
Nerve Damage	16	16
Cerebrospinal Fluid Leakage	15	15
Not Applicable	15	15
Spinal Column Injury	14	14
Unspecified Nervous System Problem	12	12
Deformity/ Disfigurement	10	10
Hip Fracture	10	10
Muscle Weakness	10	10
Loss of Range of Motion	9	9
Fibrosis	8	8
Complaint, Ill-Defined	7	7
Hemorrhage/Bleeding	7	7
Post Operative Wound Infection	6	6
Ambulation Difficulties	6	6
Missing Value Reason	5	5
Joint Dislocation	5	5
Erosion	5	5
Wound Dehiscence	4	4
Fall	4	4
Damage to Ligament(s)	4	4
Seroma	4	4
Paresis	3	3
Swelling	3	3
Numbness	3	3
Neuropathy	3	3
Inflammation	3	3
Headache	3	3
Hematoma	3	3
Aspiration/Inhalation	3	3
Bacterial Infection	3	3
Muscle/Tendon Damage	3	3
Swelling/ Edema	3	3
Physical Asymmetry	2	2
Peripheral Nervous Injury	2	2
Osteopenia/ Osteoporosis	2	2
Tissue Breakdown	2	2
Blood Loss	2	2
Test Result	2	2
Burn(s)	2	2
Fever	2	2
Arthritis	2	2
Paralysis	2	2
Dizziness	2	2
Spinal Cord Injury	2	2
Scar Tissue	2	2
Perforation of Vessels	2	2
Weakness	1	1
Discharge	1	1
Shock	1	1
Urinary Retention	1	1
Perforation	1	1
Synovitis	1	1
Therapeutic Effects, Unexpected	1	1
Thrombosis	1	1
Thrombus	1	1
Paraplegia	1	1
Needle Stick/Puncture	1	1
Collapse	1	1
Irritability	1	1
Osteolysis	1	1
Non-union Bone Fracture	1	1
Joint Disorder	1	1
Hypoesthesia	1	1
Joint Swelling	1	1
Neurological Deficit/Dysfunction	1	1
Incontinence	1	1
Irritation	1	1
Infiltration into Tissue	1	1
Chest Pain	1	1
Cyst(s)	1	1
Deposits	1	1
Dysphagia/ Odynophagia	1	1
Dyspnea	1	1
Cellulitis	1	1
Stroke/CVA	1	1
Abscess	1	1
Achalasia	1	1
Patient Problem/Medical Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Blue Ortho	II	Oct-23-2020
2	Blue Ortho	II	Feb-11-2020
3	Brainlab AG	II	Aug-29-2020
4	Brainlab AG	II	Aug-13-2020
5	Brainlab AG	II	Oct-11-2018
6	DePuy Orthopaedics, Inc.	II	May-02-2022
7	Exactech, Inc.	II	Jan-18-2018
8	Intellijoint Surgical, Inc.	II	Mar-23-2020
9	Intellijoint Surgical, Inc.	II	Aug-08-2019
10	K2M, Inc	II	Oct-07-2019
11	Mako Surgical Corporation	II	Sep-09-2022
12	Mako Surgical Corporation	II	Nov-19-2020
13	Mako Surgical Corporation	II	Jul-31-2020
14	Mako Surgical Corporation	II	Jun-16-2019
15	Mako Surgical Corporation	II	Sep-15-2018
16	Mako Surgical Corporation	II	Aug-24-2018
17	Mako Surgical Corporation	II	Aug-14-2018
18	Mako Surgical Corporation	II	May-04-2018
19	Mako Surgical Corporation	II	Sep-13-2017
20	Mako Surgical Corporation	II	Jul-18-2017
21	Mako Surgical Corporation	II	Mar-07-2017
22	Mako Surgical Corporation	II	Feb-11-2017
23	Mazor Robotics Ltd	II	Dec-20-2019
24	Medtronic Navigation, Inc.	II	Jun-09-2020
25	Medtronic Navigation, Inc.	II	Apr-10-2020
26	Medtronic Navigation, Inc.	II	Dec-19-2019
27	Medtronic Navigation, Inc.	II	Sep-21-2017
28	OMNIlife science Inc.	II	Jun-04-2019
29	Orthosoft, Inc. dba Zimmer CAS	II	Mar-03-2022
30	Orthosoft, Inc. dba Zimmer CAS	II	Apr-26-2017
31	Orthosoft, Inc. dba Zimmer CAS	II	Apr-19-2017
32	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Nov-02-2020
33	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Oct-31-2020
34	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Oct-27-2020
35	Smith & Nephew, Inc.	II	Apr-01-2020
36	Think Surgical, Inc.	II	Aug-06-2018
37	Zimmer Biomet, Inc.	II	Feb-16-2018
38	Zimmer Biomet, Inc.	II	Nov-28-2017
39	Zimmer Biomet, Inc.	II	Mar-27-2017