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	1624	1634
Break	872	879
Adverse Event Without Identified Device or Use Problem	599	601
Material Deformation	419	420
Material Twisted/Bent	262	264
Unstable	161	161
Fracture	134	137
Mechanical Jam	87	89
Material Integrity Problem	68	68
Entrapment of Device	59	60
Detachment of Device or Device Component	46	47
Use of Device Problem	44	45
Contamination /Decontamination Problem	34	34
Packaging Problem	30	30
No Apparent Adverse Event	28	28
Crack	25	25
Device Slipped	21	21
Mechanical Problem	20	20
Material Separation	18	18
Failure to Align	13	13
Tear, Rip or Hole in Device Packaging	13	13
Appropriate Term/Code Not Available	11	12
Device Contaminated During Manufacture or Shipping	11	11
Material Discolored	9	9
Corroded	8	8
Manufacturing, Packaging or Shipping Problem	8	8
Separation Failure	8	8
Scratched Material	8	8
Physical Resistance/Sticking	8	8
Loose or Intermittent Connection	7	7
Degraded	6	6
Positioning Failure	5	5
Improper or Incorrect Procedure or Method	5	5
Defective Device	5	5
Connection Problem	5	5
Compatibility Problem	5	5
Device Handling Problem	4	4
Failure to Cut	4	4
Fitting Problem	4	4
Unsealed Device Packaging	4	4
Naturally Worn	4	4
Incomplete or Inadequate Connection	4	4
Failure to Clean Adequately	3	3
Unintended Movement	3	3
Difficult to Remove	3	3
Difficult to Insert	3	3
Difficult to Advance	3	3
Component Missing	3	3
Noise, Audible	3	3
Labelling, Instructions for Use or Training Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3019	3037
Insufficient Information	296	301
Unspecified Infection	240	240
Joint Laxity	234	234
Foreign Body In Patient	87	88
Implant Pain	48	48
Bone Fracture(s)	16	16
Loss of Range of Motion	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Failure of Implant	11	11
Unspecified Tissue Injury	11	11
Fall	10	10
Muscle/Tendon Damage	5	5
Pain	5	5
Joint Dislocation	4	4
Hypersensitivity/Allergic reaction	3	3
Hematoma	3	3
Limb Fracture	3	3
No Patient Involvement	3	3
Device Embedded In Tissue or Plaque	2	2
Inflammation	2	2
Burn(s)	2	2
Numbness	2	2
Osteolysis	2	2
Infiltration into Tissue	1	1
Hemorrhage/Bleeding	1	1
Bacterial Infection	1	1
Abscess	1	1
Muscular Rigidity	1	1
Osteomyelitis	1	1
Fever	1	1
Reaction to Medicinal Component of Device	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Rupture	1	1
Purulent Discharge	1	1
Anemia	1	1
Abrasion	1	1
Cyst(s)	1	1
Skin Inflammation/ Irritation	1	1
Inadequate Osseointegration	1	1
Fatigue	1	1
Arthralgia	1	1
Wound Dehiscence	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