STRYKER GMBH SYMPHYSIS-PUBIS PLATE, RADIUS 75 HOLES 6 LENGTH 92.5MM FOR SCREWS 3.5/4.5MM; PLATE, FIXATION, BONE
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Catalog Number 425796S |
Device Problems
Material Discolored (1170); Tear, Rip or Hole in Device Packaging (2385)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This device is not cleared for sale in the us, however a similar device is cleared for sale in the us.Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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Customer reported that the sterile packaging of the 2x products had a cut in the inner wrap.The customer noted that the product appeared to be slightly blue.Customer used alternative plate to complete the case.
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Manufacturer Narrative
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Correction: refer to d4 lot#, d9/h3 device availability.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.No additional information was provided even after multiple attempts.A review of the device history was not possible because the correct lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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Customer reported that the sterile packaging of the 2x products had a cut in the inner wrap.The customer noted that the product appeared to be slightly blue.Customer used alternative plate to complete the case.
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Search Alerts/Recalls
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