MEDOS INTERNATIONAL SÃ RL RGDLOOP ADJUSTABLE STND; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 232447 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.Udi: (b)(4).H4: the device manufacture date is currently unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Event Description
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This is report 1 of 3 for (b)(4).It was reported by the patient that during an anterior/medial cruciate ligament reconstruction procedure on an unknown date on (b)(6) 2023, a rgdloop adjustable stnd device, milagro advance screw 8x30mm device and milagro advance screw 9x30mm device were implanted on her knee.According to the patient, she's been having sensitivity in the area of the implant (screw) - top of the tibia below the knee, where the acl connection was.Patient reported that over time, she has a palpable lump in the area of the implant which she could not kneel without discomfort; and symptoms never subsided post-op.Patient reported that she has been scheduled for the removal of the implants in a month.No additional information was provided.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary = > the complaint device is not being returned, it was implanted in the customer, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the reported complaint condition were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Search Alerts/Recalls
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