CMF Matrix Screws in Clips 의 안전성 경고

Safety alert

2013-04-16

2013-04-16

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130416a.html

Medical device safety alert: synthes cmf matrix screws in clips medical device manufacturer, synthes, has issued a field safety notice concerning the cmf matrix screws in clips. the affected products are matrixmandible, matrixmidface, matrixneuro and matrixorthognathic. according to the manufacturer, starting in 2011, twelve complaints have been received regarding matrix screws packaged in screw clips. none of the complaints were patient related, as all non-conformances were detected while restocking the implant modules. the issue is limited to the clip itself and the etching on the clip. the screw length indicated on the package label corresponds to the length of the screw in the package. the root cause of the possible deviation is an incorrect assembly for the screw into the clip at manufacturing facility monument/usa. regarding matrix midface, mandible and orthognathic, it is not likely that the presence of a screw that is packaged in the incorrect clip holder will result in a serious adverse event. there is a remote probability that a medically reversible or transient adverse health event will result due to a screw being packaged in the incorrect clip holder. regarding matrix neuro, there is a remote probability that the presence of a screw that is packaged in the incorrect clip holder will result in a serious adverse event, including death. there is a remote probability that a medically reversible or transient adverse health event will result due to a screw being packaged in the incorrect clip holder there is the potential specific to matrix neuro screws, where the incorrect screw length being utilized may result in a life-threatening event for population at greatest risk (pediatric patients; pediatric and adult patients with skull deformities/lesions; patients with previous diseases of the bone or bone metabolism resulting in bone mass reduction). the manufacturer strongly urges the user to return the identified devices and replacement product will be provided once it becomes available. however, due to the medical importance of these products and the potential lack of readily available alternative products, a secondary alternative is being provided. if returning them would adversely impact the ability to provide necessary medical care to patients the customers may measure the screws prior to use, using the measuring scale provided in the graphic case, and utilize them as needed. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 april 2013.