PMID- 36594981
OWN - NLM
STAT- MEDLINE
DCOM- 20230105
LR  - 20230111
IS  - 1548-825X (Print)
IS  - 1548-825X (Linking)
VI  - 31
IP  - 4
DP  - 2022 Winter
TI  - Categorization of Adverse Events Reported to the FDA Pertaining to Tibia 
      Intramedullary Nailing.
PG  - 237-241
AB  - OpenFDA is an open access database maintained by the United States Food and Drug 
      Administration (FDA) that we queried for adverse events (AEs) related to product 
      devices used during tibia intramedullary nailing (IMN) procedures. There was a 
      total of 1,799 reports pertaining to tibial intramedullary nailing from 1996 to 
      2020. Causes included infection (451), nonunion (380), intraoperative issue 
      (343), painful hardware (234), implant fracture (195), other (68), loosening 
      (35), surgeon error (24), packing problem (24), patient injury (12), expiration 
      (12), contamination (11) and allergic reaction (10). The total number of events 
      increased in 2016 and 2018, which was attributed to 510k approval for Stryker. Of 
      the Aes, 1,400 resulted in an injury to the patient. In total, 78% occurred in 
      the post-operative period, and 68% required additional surgery. Most incidents 
      related to tibia IMNs result in injury and require additional surgery. When new 
      products are released, AEs occur quickly and in bulk. (Journal of Surgical 
      Orthopaedic Advances 31(4):237-241, 2022).
FAU - Provenzano, Gina
AU  - Provenzano G
AD  - Ascension Providence Hospital, Southfield Hospital, Southfield, Michigan.
FAU - Provenzano, Destie
AU  - Provenzano D
AD  - George Washington University School of Engineering and Applied Science, 
      Department of Biomedical Engineering, Washington DC.
FAU - Best, Benjamin J
AU  - Best BJ
AD  - Ascension St. John Hospital, Detroit, Michigan.
FAU - Afsari, Alan
AU  - Afsari A
AD  - Ascension St. John Hospital, Detroit, Michigan.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - J Surg Orthop Adv
JT  - Journal of surgical orthopaedic advances
JID - 101197881
SB  - IM
MH  - United States/epidemiology
MH  - Humans
MH  - *Fracture Fixation, Intramedullary/adverse effects
MH  - Tibia/surgery
MH  - United States Food and Drug Administration
MH  - *Tibial Fractures/surgery
MH  - Fracture Fixation, Internal/methods
MH  - Treatment Outcome
MH  - Bone Nails/adverse effects
MH  - Retrospective Studies
MH  - Fracture Healing
EDAT- 2023/01/04 06:00
MHDA- 2023/01/06 06:00
CRDT- 2023/01/03 11:13
PHST- 2023/01/03 11:13 [entrez]
PHST- 2023/01/04 06:00 [pubmed]
PHST- 2023/01/06 06:00 [medline]
AID - https://www.jsoaonline.com/archive/2022/winter-2022/categorization-of-adverse-events-reported-to-the-fda-pertaining-to-tibia-intramedullary-nailing/ 
      [pii]
PST - ppublish
SO  - J Surg Orthop Adv. 2022 Winter;31(4):237-241.