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
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	4
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	2
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	5
HANGZHOU LANCET ROBOTICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOVASIS, INC.
	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	5
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
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	2
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
NOVARAD CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	4
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	4
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	2
ORTHOSOFT, INC (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	2
ORTOMA AB
	SUBSTANTIALLY EQUIVALENT	1
OSSEUS FUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
PATHKEEPER SURGICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIXEE MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
POINT ROBOTICS MEDTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
PRACTICAL NAVIGATION, LLC
	SUBSTANTIALLY EQUIVALENT	1
PRECISION SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	3
PREMIA SPINE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PROPRIO, INC.
	SUBSTANTIALLY EQUIVALENT	1
REMEX MEDICAL CORP.
	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	2
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	6
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
2023	458	458

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1107	1107
Material Integrity Problem	1067	1067
Mechanical Problem	772	772
Use of Device Problem	493	493
Fracture	441	441
Non Reproducible Results	435	435
Insufficient Information	421	421
Unintended Application Program Shut Down	417	417
Computer Software Problem	402	402
Application Program Problem: Parameter Calculation Error	338	338
Detachment of Device or Device Component	332	332
Imprecision	316	316
Connection Problem	315	315
Adverse Event Without Identified Device or Use Problem	236	236
Output Problem	218	218
Incorrect, Inadequate or Imprecise Result or Readings	215	215
Material Deformation	202	202
Physical Resistance/Sticking	181	181
Material Twisted/Bent	172	172
Device Slipped	170	170
Unintended Movement	153	153
Application Program Problem	150	150
Residue After Decontamination	137	137
Mechanical Jam	133	133
Defective Component	127	127
Device-Device Incompatibility	121	121
Solder Joint Fracture	110	110
Display or Visual Feedback Problem	107	107
Positioning Problem	97	97
Failure to Calibrate	93	93
Overheating of Device	90	90
Mechanics Altered	88	88
Positioning Failure	81	81
Malposition of Device	76	76
Intermittent Communication Failure	67	67
Appropriate Term/Code Not Available	64	64
Loose or Intermittent Connection	64	64
Failure to Recalibrate	62	62
Circuit Failure	58	58
Noise, Audible	57	57
Material Frayed	56	56
Application Program Freezes, Becomes Nonfunctional	52	52
Image Display Error/Artifact	51	51
Device Sensing Problem	49	49
Electrical /Electronic Property Problem	41	41
No Apparent Adverse Event	40	40
Difficult to Insert	39	39
Computer Operating System Problem	37	37
Improper or Incorrect Procedure or Method	37	37
Incorrect Measurement	34	34
Defective Device	33	33
Premature Separation	32	32
Inappropriate Tactile Prompt/Feedback	30	30
Calibration Problem	30	30
Failure to Power Up	30	30
Crack	30	30
Material Fragmentation	29	29
Device Operates Differently Than Expected	28	28
Electrical Power Problem	27	27
Difficult to Remove	27	27
Complete Loss of Power	27	27
Entrapment of Device	26	26
Deformation Due to Compressive Stress	26	26
Unstable	26	26
Contamination /Decontamination Problem	25	25
Contamination of Device Ingredient or Reagent	25	25
Intermittent Loss of Power	25	25
Communication or Transmission Problem	24	24
No Display/Image	24	24
Naturally Worn	23	23
Difficult or Delayed Positioning	22	22
Suction Problem	22	22
Device Dislodged or Dislocated	21	21
Retraction Problem	20	20
Material Split, Cut or Torn	20	20
No Visual Prompts/Feedback	19	19
Inadequacy of Device Shape and/or Size	18	18
Image Orientation Incorrect	17	17
Bent	16	16
Operating System Becomes Nonfunctional	16	16
Power Problem	16	16
Sharp Edges	15	15
Degraded	15	15
Fluid/Blood Leak	15	15
Electrical Shorting	15	15
Battery Problem	15	15
Separation Failure	14	14
Component Missing	13	13
Loss of Osseointegration	13	13
Contamination	13	13
Erratic or Intermittent Display	12	12
Unintended System Motion	12	12
Fitting Problem	12	12
Failure to Align	12	12
Off-Label Use	11	11
Separation Problem	11	11
Corroded	10	10
Device Displays Incorrect Message	10	10
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	3853	3861
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	122	122
Unspecified Tissue Injury	116	116
Pain	109	109
Insufficient Information	95	95
Bone Fracture(s)	78	78
Unspecified Infection	48	48
Tissue Damage	48	48
No Information	43	43
No Code Available	42	42
Device Embedded In Tissue or Plaque	37	37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Laceration(s)	22	22
Failure of Implant	21	21
Nerve Damage	20	20
Joint Laxity	20	20
Discomfort	19	19
Cerebrospinal Fluid Leakage	18	18
Inadequate Osseointegration	17	17
Unspecified Nervous System Problem	16	16
Muscle Weakness	15	15
Not Applicable	13	13
Hip Fracture	10	10
Deformity/ Disfigurement	10	10
Post Operative Wound Infection	9	9
Loss of Range of Motion	9	9
Spinal Column Injury	9	9
Hemorrhage/Bleeding	9	9
Fibrosis	8	8
Complaint, Ill-Defined	7	7
Iatrogenic Source	7	7
Ambulation Difficulties	7	7
Numbness	6	6
Joint Dislocation	5	5
Damage to Ligament(s)	5	5
Erosion	5	5
Missing Value Reason	5	5
Swelling/ Edema	4	4
Wound Dehiscence	4	4
Fall	4	4
Paralysis	4	4
Paresis	4	4
Seroma	4	4
Perforation	3	3
Neuropathy	3	3
Headache	3	3
Hematoma	3	3
Aspiration/Inhalation	3	3
Bacterial Infection	3	3
Muscle/Tendon Damage	3	3
Tissue Breakdown	3	3
Fluid Discharge	2	2
Osteopenia/ Osteoporosis	2	2
Test Result	2	2
Peripheral Nervous Injury	2	2
Physical Asymmetry	2	2
Fever	2	2
Scar Tissue	2	2
Swelling	2	2
Rupture	2	2
Urinary Retention	2	2
Dizziness	2	2
Spinal Cord Injury	2	2
Blood Loss	2	2
Lethargy	1	1
Skin Tears	1	1
Sleep Dysfunction	1	1
Paraplegia	1	1
Needle Stick/Puncture	1	1
Collapse	1	1
Non-union Bone Fracture	1	1
Hypoesthesia	1	1
Perforation of Vessels	1	1
Weakness	1	1
Discharge	1	1
Synovitis	1	1
Therapeutic Effects, Unexpected	1	1
Thrombosis	1	1
Thrombus	1	1
Shock	1	1
Chest Pain	1	1
Cyst(s)	1	1
Deposits	1	1
Dysphagia/ Odynophagia	1	1
Dyspnea	1	1
Erythema	1	1
Abscess	1	1
Achalasia	1	1
Burn(s)	1	1
Cardiac Arrest	1	1
Cellulitis	1	1
Stroke/CVA	1	1
Neurological Deficit/Dysfunction	1	1
Infiltration into Tissue	1	1
Inflammation	1	1
Intracranial Hemorrhage	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	Mar-28-2023
5	Brainlab AG	II	Aug-29-2020
6	Brainlab AG	II	Aug-13-2020
7	Brainlab AG	II	Oct-11-2018
8	DePuy Orthopaedics, Inc.	II	May-02-2022
9	Exactech, Inc.	II	Jan-18-2018
10	Intellijoint Surgical, Inc.	II	Mar-23-2020
11	Intellijoint Surgical, Inc.	II	Aug-08-2019
12	K2M, Inc	II	Oct-07-2019
13	Mako Surgical Corporation	II	Sep-09-2022
14	Mako Surgical Corporation	II	Nov-19-2020
15	Mako Surgical Corporation	II	Jul-31-2020
16	Mako Surgical Corporation	II	Jun-16-2019
17	Mako Surgical Corporation	II	Sep-15-2018
18	Mako Surgical Corporation	II	Aug-24-2018
19	Mako Surgical Corporation	II	Aug-14-2018
20	Mako Surgical Corporation	II	May-04-2018
21	Mazor Robotics Ltd	II	Dec-20-2019
22	Medacta Usa Inc	II	Dec-03-2022
23	Medtronic Navigation, Inc.	II	Jun-09-2020
24	Medtronic Navigation, Inc.	II	Apr-10-2020
25	Medtronic Navigation, Inc.	II	Dec-19-2019
26	NuVasive Inc	III	Feb-03-2023
27	OMNIlife science Inc.	II	Jun-04-2019
28	Orthosoft, Inc. dba Zimmer CAS	II	Mar-03-2022
29	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Nov-02-2020
30	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Oct-31-2020
31	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Oct-27-2020
32	Smith & Nephew, Inc.	II	Apr-01-2020
33	Think Surgical, Inc.	II	Aug-06-2018
34	Zimmer Biomet, Inc.	II	Feb-16-2018