TPLC - Total Product Life Cycle

• Device: fastener, plate, cranioplasty
• Product Code: HBW
• Regulation Number: 882.5360
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
POREX SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	2
STRYKER LEIBINGER GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	3	3
2017	14	14
2018	22	22
2019	20	20
2020	1	1
2021	2	2
2022	2	2
2023	1	1
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	23	23
Fracture	10	10
Device Slipped	8	8
Break	6	6
Detachment of Device or Device Component	6	6
Device Operates Differently Than Expected	3	3
Material Fragmentation	2	2
Difficult to Insert	2	2
Device Handling Problem	2	2
Device Appears to Trigger Rejection	2	2
Fitting Problem	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Use of Device Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Migration	1	1
Patient-Device Incompatibility	1	1
Insufficient Information	1	1
Deformation Due to Compressive Stress	1	1
Detachment Of Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	25	25
No Consequences Or Impact To Patient	15	15
No Known Impact Or Consequence To Patient	9	9
Foreign Body In Patient	4	4
Impaired Healing	3	3
No Clinical Signs, Symptoms or Conditions	2	2
No Information	2	2
Cerebrospinal Fluid Leakage	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Failure of Implant	1	1
Brain Injury	1	1
No Code Available	1	1
Foreign Body Reaction	1	1
Visual Impairment	1	1
Bacterial Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Synthes (USA) Products LLC	II	Mar-01-2024