Model Number GLENOID SPHERE Ø36/Ø29/CENTERED |
Device Problem
Device Difficult to Setup or Prepare (1487)
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Patient Problem
Failure of Implant (1924)
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Event Date 06/09/2016 |
Event Type
malfunction
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Manufacturer Narrative
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On (b)(6) 2020 stryker trauma and extremities acquired tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr process.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.Based on the x-rays available, no issue can be reported.The glenoid sphere seems being well impacted.The problem is probably linked with engagement issue of the screw into the baseplate before disengaging from the glenosphere.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.
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Event Description
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The screw would not engage the baseplate (when he went to screw, after impacting).The center screw kept spinning.The glenoid spere was left in patient.Dr.Felt the sphere was still attached to the baseplate in a sound & secure fashion.
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Search Alerts/Recalls
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