Catalog Number 14-500361 |
Device Problems
Fracture (1260); Physical Resistance/Sticking (4012)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 02/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2020-00208 to 3012447612-2020-00211.
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Event Description
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It was reported that during the procedure the k-wires were binding inside the pedicle screws during screw installation.The tips of two wires broke off and were retained within the pedicles of l5 and s1.There were no additional patient impacts reported.This is report one of four for this event.
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Event Description
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It was reported that during the procedure the k-wires were binding inside the pedicle screws during screw installation.The tips of two wires broke off and were retained within the pedicles of l5 and s1.There were no additional patient impacts reported.Additional information was provided stating that the patient underwent a revision surgery and removed the two screws.However, it was not stated that k-wires, retained in the pedicles, were able to be removed.This is report one of four for this event.
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Manufacturer Narrative
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Additional information in: a1, a2 (date of birth), a4, a5, b5, and b7.
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Manufacturer Narrative
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Additional information in h6: method, results, and conclusions.The device was not returned for evaluation, however, x-rays were provided which confirms that the tip of the guidewire broke off at the tip of the screw.Since the device was unable to be evaluated, there are no results available and the cause cannot be determined.The dhr was unable to be reviewed since the lot number is unknown.The labeling was reviewed and found to contain instructions regarding proper device usage.
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Event Description
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It was reported that during the procedure the k-wires were binding inside the pedicle screws during screw installation.The tips of two wires broke off and were retained within the pedicles of l5 and s1.There were no additional patient impacts reported.Additional information was provided stating that the patient underwent a revision surgery and removed the two screws.However, it was not stated that k-wires, retained in the pedicles, were able to be removed.This is report one of four for this event.
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Manufacturer Narrative
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The portion of the guide wire that broke off and was retained by the patient was removed along with the implant construct on (b)(6) 2020.A photo was provided which showed the piece had fractured as reported and was removed from the patient.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that during the procedure the k-wires were binding inside the pedicle screws during screw installation.The tips of two wires broke off and were retained within the pedicles of l5 and s1.There were no additional patient impacts reported.Additional information was provided stating that the patient underwent a revision surgery and removed the two screws.However, it was not stated that k-wires, retained in the pedicles, were able to be removed.This is report one of four for this event.
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Search Alerts/Recalls
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