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Model Number 25MM CENTRAL SCREW, MODULAR |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported on 09/22/2022 by a sales representative via email that an ar-9560-28-2 baseplate and ar-9561-25s modular screw would not compress together with the morse taper using the taper assembly press.This was discovered during a case with no patient harm.Per facility: " it was confirmed that the compression line between maximum and minimum was achieved but up insterting the implant the two pieces became disassembled.We were able to retrieve both parts safely without harming the patient.We then assembled two new parts, same sizes, and in the same fashion without issues.".
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Manufacturer Narrative
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Complaint is confirmed.One unpackaged ar-9561-25s, 25mm central screw, modular serial/batch number (b)(6), was received for investigation.Functional testing found that the device does not attach to the returned ar-9560-28-2 - 28mm +2 lat baseplate, modular.Visual evaluation found that the central screw taper connector hex was damaged, losing its geometry form.Complaint use error.
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Search Alerts/Recalls
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