STRYKER GMBH SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 7 HOLE / LEFT; PLATE, FIXATION, BONE
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Model Number 628007S |
Device Problem
Separation Problem (4043)
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Patient Problems
Failure of Implant (1924); Impaired Healing (2378)
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Event Date 10/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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As reported: "a (b)(6)-year-old female pt underwent the clavicle joint surgery (left) on (b)(6) 2020.After the operation, the plate moved and the screw came off the plate, and the revision surgery was performed on (b)(6) 2020.".
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Manufacturer Narrative
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The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received plate found completely intact with no deformation.The hole where bone screw was placed observed without any defects on its surface.However, the hole where locking screw was placed was observed with minor chipping off, of the metals at rim due to insertion of locking screw.The inspection does not indicate any device related issue for the reported failure.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused due to screws did not hold to the specified location which resulted in separation of screws from the plate.Considering the age of the patient & opinion from the sr, failure mode is more attributable to patient related ( weak bone quality, patient activity etc.) if any further information is provided, the complaint report will be updated.
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Event Description
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As reported: "a 90-year-old female pt underwent the clavicle joint surgery (left) on (b)(6) 2020.After the operation, the plate moved and the screw came off the plate, and the revision surgery was performed on (b)(6) 2020".
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Event Description
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As reported: "a 90-year-old female pt underwent the clavicle joint surgery (left) on (b)(6) 2020.After the operation, the plate moved and the screw came off the plate, and the revision surgery was performed on (b)(6) 2020.".
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Manufacturer Narrative
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Please note corrections to clinical sign code h6, results code h6.
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