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	2
BLUE BELT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	8
BLUE ORTHO
	SUBSTANTIALLY EQUIVALENT	3
BRAINLAB AG
	SUBSTANTIALLY EQUIVALENT	9
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	2
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	1
ECENTIAL ROBOTICS
	SUBSTANTIALLY EQUIVALENT	1
FUSION ROBOTICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	5
HANGZHOU LANCET ROBOTICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INSIGHT MEDICAL SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	1
INTAI TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INTEGRITY IMPLANTS INC.
	SUBSTANTIALLY EQUIVALENT	1
INTELLIJOINT SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
IZI MEDICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
K2M
	SUBSTANTIALLY EQUIVALENT	2
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	2
KICO KNEE INNOVATION COMPANY PTY LIMITED
	SUBSTANTIALLY EQUIVALENT	2
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1
MAKO SURGICAL CORP.
	SUBSTANTIALLY EQUIVALENT	4
MAZOR ROBOTICS LTD.
	SUBSTANTIALLY EQUIVALENT	4
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	4
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	1
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	3
ORTHALIGN INC
	SUBSTANTIALLY EQUIVALENT	1
ORTHALIGN, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOKEY ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS, CORP.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSOFT D/B/A ZIMMER CAS
	SUBSTANTIALLY EQUIVALENT	3
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	2
SI-BONE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	1
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
TAIWAN MAIN ORTHOPAEDIC BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THINK SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5
TORNIER SAS
	SUBSTANTIALLY EQUIVALENT	1
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
2018	1233	1233
2019	1585	1585
2020	2744	2744
2021	1699	1699
2022	1570	1578

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1070	1070
Material Integrity Problem	1053	1053
Mechanical Problem	764	764
Non Reproducible Results	435	435
Fracture	432	432
Use of Device Problem	431	431
Insufficient Information	415	415
Computer Software Problem	402	402
Unintended Application Program Shut Down	367	367
Detachment of Device or Device Component	319	319
Application Program Problem: Parameter Calculation Error	315	315
Connection Problem	296	296
Imprecision	281	281
Adverse Event Without Identified Device or Use Problem	229	229
Output Problem	211	211
Material Deformation	200	200
Incorrect, Inadequate or Imprecise Result or Readings	178	178
Physical Resistance/Sticking	169	169
Material Twisted/Bent	168	168
Application Program Problem	147	147
Unintended Movement	138	138
Device Slipped	135	135
Defective Component	127	127
Mechanical Jam	127	127
Residue After Decontamination	112	112
Solder Joint Fracture	110	110
Display or Visual Feedback Problem	106	106
Overheating of Device	89	89
Positioning Problem	86	86
Mechanics Altered	85	85
Device-Device Incompatibility	85	85
Failure to Calibrate	78	78
Positioning Failure	74	74
Intermittent Communication Failure	66	66
Failure to Recalibrate	62	62
Loose or Intermittent Connection	60	60
Appropriate Term/Code Not Available	59	59
Circuit Failure	58	58
Malposition of Device	57	57
Material Frayed	56	56
Noise, Audible	53	53
Image Display Error/Artifact	51	51
Device Sensing Problem	48	48
Application Program Freezes, Becomes Nonfunctional	46	46
Electrical /Electronic Property Problem	40	40
Difficult to Insert	38	38
No Apparent Adverse Event	36	36
Computer Operating System Problem	34	34
Defective Device	32	32
Incorrect Measurement	32	32
Premature Separation	31	31
Failure to Power Up	30	30
Crack	30	30
Calibration Problem	30	30
Inappropriate Tactile Prompt/Feedback	29	29
Device Operates Differently Than Expected	28	28
Improper or Incorrect Procedure or Method	28	28
Material Fragmentation	28	28
Difficult to Remove	27	27
Electrical Power Problem	27	27
Deformation Due to Compressive Stress	26	26
Complete Loss of Power	26	26
Contamination /Decontamination Problem	25	25
Contamination of Device Ingredient or Reagent	25	25
Entrapment of Device	25	25
Intermittent Loss of Power	24	24
No Display/Image	23	23
Communication or Transmission Problem	23	23
Naturally Worn	22	22
Suction Problem	22	22
Unstable	22	22
Difficult or Delayed Positioning	22	22
Device Dislodged or Dislocated	20	20
Material Split, Cut or Torn	20	20
Retraction Problem	19	19
Inadequacy of Device Shape and/or Size	18	18
Image Orientation Incorrect	17	17
Bent	16	16
Power Problem	16	16
Operating System Becomes Nonfunctional	16	16
Sharp Edges	15	15
No Visual Prompts/Feedback	15	15
Degraded	15	15
Fluid/Blood Leak	15	15
Electrical Shorting	15	15
Battery Problem	14	14
Separation Failure	13	13
Loss of Osseointegration	13	13
Fitting Problem	12	12
Failure to Align	12	12
Contamination	12	12
Off-Label Use	11	11
Separation Problem	11	11
Unintended System Motion	10	10
Erratic or Intermittent Display	10	10
Device Displays Incorrect Message	10	10
Corroded	9	9
Nonstandard Device	9	9
Device Difficult to Setup or Prepare	9	9
Material Separation	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3450	3458
No Known Impact Or Consequence To Patient	2901	2901
No Patient Involvement	1147	1147
No Consequences Or Impact To Patient	720	720
Injury	317	317
Foreign Body In Patient	119	119
Pain	106	106
Unspecified Tissue Injury	94	94
Insufficient Information	92	92
Bone Fracture(s)	70	70
Tissue Damage	48	48
Unspecified Infection	48	48
No Information	43	43
No Code Available	42	42
Device Embedded In Tissue or Plaque	35	35
Failure of Implant	21	21
Laceration(s)	20	20
Discomfort	19	19
Joint Laxity	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Nerve Damage	18	18
Inadequate Osseointegration	17	17
Cerebrospinal Fluid Leakage	17	17
Not Applicable	13	13
Unspecified Nervous System Problem	13	13
Muscle Weakness	11	11
Hip Fracture	10	10
Deformity/ Disfigurement	10	10
Spinal Column Injury	9	9
Hemorrhage/Bleeding	9	9
Loss of Range of Motion	9	9
Fibrosis	8	8
Iatrogenic Source	7	7
Complaint, Ill-Defined	7	7
Post Operative Wound Infection	7	7
Ambulation Difficulties	6	6
Joint Dislocation	5	5
Erosion	5	5
Damage to Ligament(s)	5	5
Missing Value Reason	5	5
Seroma	4	4
Swelling/ Edema	4	4
Fall	4	4
Paresis	4	4
Aspiration/Inhalation	3	3
Hematoma	3	3
Bacterial Infection	3	3
Numbness	3	3
Neuropathy	3	3
Wound Dehiscence	3	3
Muscle/Tendon Damage	3	3
Headache	3	3
Paralysis	2	2
Scar Tissue	2	2
Blood Loss	2	2
Dizziness	2	2
Tissue Breakdown	2	2
Test Result	2	2
Physical Asymmetry	2	2
Rupture	2	2
Peripheral Nervous Injury	2	2
Fever	2	2
Osteopenia/ Osteoporosis	2	2
Spinal Cord Injury	2	2
Swelling	2	2
Fluid Discharge	2	2
Embolism/Embolus	1	1
Thrombosis	1	1
Discharge	1	1
Hypoesthesia	1	1
Collapse	1	1
Skin Tears	1	1
Intracranial Hemorrhage	1	1
Inflammation	1	1
Neurological Deficit/Dysfunction	1	1
Burn(s)	1	1
Cyst(s)	1	1
Deposits	1	1
Dyspnea	1	1
Cellulitis	1	1
Stroke/CVA	1	1
Urinary Retention	1	1
Non-union Bone Fracture	1	1
Shock	1	1
Movement Disorder	1	1
Patient Problem/Medical Problem	1	1
Injection Site Reaction	1	1
Lethargy	1	1
Abscess	1	1
Achalasia	1	1
Dysphagia/ Odynophagia	1	1
Erythema	1	1
Perforation	1	1
Infiltration into Tissue	1	1
Sleep Dysfunction	1	1
Therapeutic Effects, Unexpected	1	1
Thrombus	1	1
Perforation of Vessels	1	1
Tactile Disorders	1	1
Vertebral Fracture	1	1

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