TPLC - Total Product Life Cycle

show TPLC since

Device	expander, surgical, skin graft
Regulation Description	Manual surgical instrument for general use.
Product Code	FZW
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	1462	1465
Material Twisted/Bent	677	677
Physical Resistance/Sticking	510	512
Appropriate Device Problem Term/Code Not Available	207	207
Material Deformation	120	122
Naturally Worn	89	89
Mechanical Problem	73	73
Retraction Problem	73	73
Failure to Advance	65	65
Fitting Problem	64	64
Break	64	64
Insufficient Device Problem Information	63	63
Patient Device Interaction Problem	61	61
Mechanical Jam	52	52
Component Missing	40	40
Delivered as Unsterile Product	39	39
Calibration Problem	35	36
Material Integrity Problem	32	32
Dull, Blunt	31	31
Difficult to Remove	27	27
Positioning Problem	18	18
Loose or Intermittent Connection	13	14
Activation, Positioning or Separation Problem	12	12
Output Problem	11	11
Activation Failure	11	11
Detachment of Device or Device Component	11	11
Difficult to Open or Close	10	10
Incorrect Measurement	10	10
No Apparent Adverse Event	9	9
Unsealed Device Packaging	8	8
Material Discolored	7	7
Activation Problem	6	6
Device Markings/Labelling Problem	6	6
Separation Failure	6	6
Difficult to Advance	6	6
Misassembled	6	6
Degraded	6	6
Failure to Align	6	6
Material Too Rigid or Stiff	6	6
Connection Problem	5	5
Device Slipped	5	5
Defective Device	5	5
Dent in Material	4	4
Noise, Audible	4	4
Electrical /Electronic Property Problem	4	4
Positioning Failure	3	3
Unstable	3	4
Failure to Disconnect	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Material Split, Cut or Torn	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2443	2451
No Patient Involvement	305	305
Insufficient Information	220	220
No Consequences Or Impact To Patient	207	207
No Known Impact Or Consequence To Patient	71	71
Laceration(s)	42	42
Abrasion	38	38
Graft failure	28	28
Skin Tears	18	18
Unspecified Tissue Injury	3	3
No Code Available	2	2
Tissue Damage	1	1
Impaired Healing	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Zimmer Surgical Inc	II	Feb-13-2024