SYNTHES GMBH 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/SM/0 DEG/RIGHT; PLATE, FIXATION, BONE
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Catalog Number 02.211.230 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint#: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d4: additional pro-code: hwc.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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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Post market study reported.It was reported that the foot plates in collaboration with depuy synthes, dr., together with cleveland clinic foundation (ccf) database designers, program managers, research assistants, and biostatisticians, has developed a report that summarizes safety and effectiveness data on 100 patients who underwent foot surgery at ccf between 2008 and 2023 utilizing depuy synthes (dps) foot plates.Some patients were noted to have adjunctive depuy synthes devices used outside of the plates/screws.Patient #30 65-year-old male was implanted with a va lcp forefoot/midfoot plates (02.211.230) with 5 screws.One additional adjunctive fixation screws was used for fixation/fusion.Post op complication was reported for painful hardware, right foot, the complication is noted to be related to the procedure or implants.There is no device failure noted.Treatment: removal of plate with 5 screws, right foot.This report is for one (1) 2.4/2.7 va first mtp fusn pl/sm/0 deg/rt.This is report 1 of 6 for complaint (b)(4).
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