TPLC - Total Product Life Cycle

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Device	guide, surgical, instrument
Regulation Description	Manual surgical instrument for general use.
Product Code	FZX
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device-Device Incompatibility	1549	1550
Break	833	834
Adverse Event Without Identified Device or Use Problem	567	567
Material Deformation	357	357
Material Twisted/Bent	234	234
Fracture	165	165
Unstable	148	148
Device Contaminated During Manufacture or Shipping	94	94
Mechanical Jam	86	86
Entrapment of Device	66	66
Material Integrity Problem	63	63
Use of Device Problem	47	47
Packaging Problem	41	41
Detachment of Device or Device Component	36	36
No Apparent Adverse Event	29	29
Contamination /Decontamination Problem	28	28
Material Separation	19	19
Crack	18	18
Appropriate Term/Code Not Available	18	18
Connection Problem	15	15
Mechanical Problem	14	14
Corroded	14	14
Degraded	14	14
Device Slipped	13	13
Failure to Align	13	13
Tear, Rip or Hole in Device Packaging	13	13
Defective Device	10	10
Manufacturing, Packaging or Shipping Problem	10	10
Physical Resistance/Sticking	9	9
Incomplete or Inadequate Connection	9	9
Component Missing	9	9
Device Markings/Labelling Problem	9	9
Separation Failure	8	8
Loose or Intermittent Connection	8	8
Scratched Material	7	7
Difficult to Remove	6	6
Difficult to Advance	5	5
Positioning Failure	5	5
Unsealed Device Packaging	4	4
Unintended Movement	4	4
Naturally Worn	4	4
Device Handling Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Failure to Cut	4	4
Compatibility Problem	4	4
Fitting Problem	4	4
Difficult or Delayed Separation	3	3
Inaccurate Information	3	3
Noise, Audible	3	3
Difficult to Insert	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2531	2532
No Consequences Or Impact To Patient	316	316
Insufficient Information	268	268
Unspecified Infection	228	228
Joint Laxity	219	219
No Patient Involvement	156	156
No Known Impact Or Consequence To Patient	92	92
Foreign Body In Patient	88	88
Implant Pain	47	47
No Code Available	45	45
Injury	20	20
No Information	16	16
Failure of Implant	14	14
Bone Fracture(s)	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Unspecified Tissue Injury	12	12
Loss of Range of Motion	11	11
Fall	7	7
Tissue Damage	5	5
Muscle/Tendon Damage	5	5
Pain	5	5
Device Embedded In Tissue or Plaque	4	4
Joint Dislocation	4	4
Not Applicable	3	3
Inflammation	3	3
Limb Fracture	3	3
Scar Tissue	2	2
Numbness	2	2
Osteolysis	2	2
Swelling	2	2
Burn(s)	2	2
Hematoma	2	2
Hypersensitivity/Allergic reaction	2	2
Osteomyelitis	1	1
Muscular Rigidity	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Rupture	1	1
Abrasion	1	1
Awareness during Anaesthesia	1	1
Perforation	1	1
Inadequate Osseointegration	1	1
Brain Injury	1	1
Swelling/ Edema	1	1
Arthralgia	1	1
Damage to Ligament(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Hologic, Inc	II	Dec-11-2024
2	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Jan-18-2024