OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 6H/RIGHT/112MM; PLATE, FIXATION, BONE
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Catalog Number 04.112.142 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Injury (2348)
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Event Date 09/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Additional procode: hwc.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from (b)(6) reports an event as follows: it was reported that a distal tibia fx surgery was performed on (b)(6) 2020.During the procedure, the doctor requested the lateral distal fibular plates, but there were no 3.5 screws because they were still in sterilization.The surgeon asked the sales representative if the placement of 2.7mm cortical screws in the body of the fibular plate but in the locking hole would work.The representative told the doctor that the indication would be 3.5 mm and that the 2.7mm could generate complications in the patient, however, the doctor proceeded to perform the surgery, knowing that the screws indicated for the body of the plate were 3.5mm.Procedure was completed successfully with no delay.Patient was stable following surgery; there were no patient consequences.This report is for a 2.7mm/3.5mm titanium (ti) locking compression plate (lcp) lateral distal fibula plate.This is report 10 of 10 for (b)(4).
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Search Alerts/Recalls
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