Events

Alerte De Sécurité sur Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Synthes.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-06-18
  • Date de publication de l'événement
    2013-06-18
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130618.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: synthes reduction instrument for spondylolisthesis, standard, for matrix 5.5 medical device manufacturer, synthes issued a medical device safety alert concerning reduction instrument for spondylolisthesis, standard, for matrix 5.5 (part number: 03.632.008; lot numbers: all). synthes received complaints that during spine surgery using the reduction instrument for spondylolisthesis, standard, for matrix 5.5 (03.632.008), the reduction insert broke and pieces broke off. once the reduction insert breaks, the instrument does not function as required. synthes explained that in a hypothetical worst case scenario, if the insert breaks and fragment(s) are retained, they may not be retrieved. additional operative time may be required to attempt retrieval and x-ray may not be effective to confirm that all fragments have been retrieved because the fragments are radiolucent. if fragments are retained there is a potential for an unfavorable response to the foreign material (chemical, biological or physical) within the body (including implant-related metal debris, wear particles, non-biocompatible materials) to occur which may trigger a localised reaction. the patient may be symptomatic requiring treatment and non-surgical treatment will not be effective as the disease progresses requiring revision surgery or reoperation. if treated on time, no permanent impairment is expected. according to the manufacturer, misassembly of the instrument in the operating room is a probable root cause of this safety issue. synthes has decided to remove the product from the market. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 jun 2013.

Device

Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5
  • Manufacturer
    Synthes

Manufacturer

Synthes