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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

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ETHICON INC. ETHILON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: injury int.J.Care injured.2008; 39: 1198¿1203.Doi: 10.1016/j.Injury.2008.05.008.[(b)(4)].
 
Event Description
It was reported via journal article: title: bridging-minimally invasive locking plate osteosynthesis (bridging-milpo): technique description with prospective series of 20 tibial fractures.Authors: timothy h.D.Williams, willem schenk.Citation: injury int.J.Care injured.2008; 39: 1198¿1203.Doi: 10.1016/j.Injury.2008.05.008.Bridging-milpo provides an alternative to other internal and external devices in the management of tibial fractures.The authors described a reproducible technique of bridging-minimally invasive locking plate osteosynthesis (bridging-milpo) in both metaphyseal and diaphyseal fractures of the tibia using a stainless steel locking compression plate (lcp) and locking screw.A total of 20 consecutive patients (14 male and 6 female patients; age range: 12 to 85 years old) with a unilateral tibial fracture were treated using bridging-milpo over a 31/2-year period between november 2003 and june 2007.During the surgical procedure, wound closure following saline wash was performed with interrupted ethilon (ethicon) to skin.Reported complications included case 2, a (b)(6)-year-old female patient with mild ankle pain, case 10, an (b)(6)-year-old female patient with wound infection which required oral antibiotics, case 14, a (b)(6)-year-old male patient with wound infection which required oral antibiotics.The hypothesized principle of relative stability was achieved through a locking plate.These show the plate in situ, bridging the fracture with a resultant lateral callus formation from the proposed micro-motion induced by immediate full weight bearing.Bridging-milpo has provided a typical pattern of fracture union through callus formation.
 
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Brand Name
ETHILON NYLON SUTURE UNKNOWN PRODUCT
Type of Device
SUTURE, NONABSORBABLE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8587186
MDR Text Key144309978
Report Number2210968-2019-81127
Device Sequence Number1
Product Code GAR
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other
Type of Report Initial
Report Date 04/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/10/2019
Initial Date FDA Received05/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age85 YR
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