TPLC - Total Product Life Cycle

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Device	probe
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HXB
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	166	166
Fracture	50	50
Material Twisted/Bent	25	25
Material Deformation	12	12
Entrapment of Device	8	8
Device-Device Incompatibility	5	5
Material Fragmentation	5	5
Material Split, Cut or Torn	3	3
Material Integrity Problem	3	3
Contamination /Decontamination Problem	3	3
Mechanical Problem	2	2
Use of Device Problem	2	2
Material Separation	2	2
Detachment of Device or Device Component	2	2
No Apparent Adverse Event	2	2
Illegible Information	2	2
Device Slipped	1	1
Defective Device	1	1
Difficult to Insert	1	1
Material Discolored	1	1
Component Missing	1	1
Incorrect Measurement	1	1
Device Dislodged or Dislocated	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	143	143
No Known Impact Or Consequence To Patient	41	41
No Consequences Or Impact To Patient	30	30
Foreign Body In Patient	27	27
Insufficient Information	9	9
Device Embedded In Tissue or Plaque	9	9
No Patient Involvement	6	6
No Code Available	4	4
Injury	2	2
Failure of Implant	1	1
Perforation	1	1
Spinal Column Injury	1	1
Unspecified Tissue Injury	1	1
Spinal Cord Injury	1	1
Excessive Tear Production	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Sklar Instruments	II	Jan-16-2025