Events

Field Safety Notices about SPIRALOK® Anchors

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by DePuy Mitek.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2012-06-09
  • Event Date Posted
    2012-10-19
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2012/10/19/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-spiralok-pla-absorbable-threaded-anchor-with-suture/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 recall data from the U.S. and Serbia.
  • Extra notes in the data
  • Reason
    The manufacturer received a report with preliminary data obtained by magnetic resonance imaging and collected during the conduct of an independent clinical study evaluating the repair of rotator cuffs. this study demonstrated the existence of an anchor fracture in 11 of 21 patients at six to nine months after surgery. 20 out of 21, or 95.2% of patients, reported good clinical outcome, and only one patient (4.8%) underwent revision surgery.

Device

SPIRALOK® Anchors

Manufacturer

DePuy Mitek