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Model Number 225-2006 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is currently pending, and a follow up report will be submitted upon completion of the investigation.Related reports: 2027754-2022-00199, 2027754-2022-00200, 2027754-2022-00201, 2027754-2022-00202, 2027754-2022-00203, 2027754-2022-00204, 2027754-2022-00205, 2027754-2022-00206, 2027754-2022-00208, 2027754-2022-00209, 2027754-2022-00210.
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Event Description
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The patient had a revision procedure on (b)(6) 2022 due to issues with the devices initially implanted on (b)(6) 2022 (previously reported in report number 2027754-2022-00142 and associated reports).After the (b)(6) 2022 revision procedure, it was reported that on (b)(6) 2022, the patient reported feeling "loose screw on the left side".It was reported a new exploration procedure was carried out, and "a new loss of the plate and bicortical screws was found".Bone material was collected, and the results are pending.The patient has not reported symptoms and imaging was performed on (b)(6) 2022 suggesting a radiolucent halo in the right side screws.The patient is currently in weekly follow-up and imaging.There is suspected metallosis.No further information has been provided.Report 9 of 12 for this event.
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Manufacturer Narrative
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The device history records (dhrs) for the provided lot numbers were individually reviewed.All inspections of all lots passed, and no issues were identified in the dhr review.All products were manufactured and inspected according to specifications.A two-year review of complaints was performed, and three other complaints for this issue were noted (complaints reported by the same physician and reported in report numbers 2027754-2022-00062, 2027754-2022-00102, 2027754-2022-00199, and their subsequent/related reports).Devices/products were not returned for further evaluation.The root cause could not be determined.
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Search Alerts/Recalls
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