SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
|
Back to Search Results |
|
Catalog Number 02.124.415 |
Device Problems
Bent (1059); Fracture (1260)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 11/23/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.An event date of (b)(6) 2015 was provided by the reporter but it is unknown if this was the date the plate actually bent and fractured or if this was the date it was discovered that the plate bent and fractured.The date the plate actually bent and fractured may be unknown.This report is for one unknown left va condylar plate, 14-hole.The reported part number, 02.124.514, is not a valid synthes part number.It is possible that the correct part number is 02.124.415 which corresponds to synthes 4.5mm variable angle locking compression curved condylar plate, 14-hole, 301mm length, left, device product codes¿(b)(4), common name¿plate, fixation, bone, (b)(4).A lot number was not provided by the reporter.The subject device is expected to be returned to the synthes manufacturer for evaluation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that an unknown variable angle (va) condylar plate, 14-hole partially broke and bent approximately three weeks after implantation on (b)(6) 2015.There were no screws at the site where the plate fractured and bent.The plate was initially implanted to treat a left femoral fracture.Revision surgery was performed on (b)(6) 2015 and the plate was removed; however, other details regarding the revision surgery are unknown.This report is for one unknown left va condylar plate, 14-hole.This report is 1 of 1 for (b)(4).
|
|
Manufacturer Narrative
|
Subject device has been received and is currently in the evaluation process.Dhr review - 02.124.415 ¿ (b)(4).Manufacturing site: (b)(4).Manufacturing date: 30.Apr.2012.Expiry date: -.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.
|
|
Manufacturer Narrative
|
Device manufacturing evaluation ¿ the plate was received in a minigrip.The reference numbers etched correspond with complaint references.The plate is bent and broken.Dhr review - no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The coa of the raw material was reviewed, no anomaly found, the material was conforming to specification.Product inspection: the returned plate was reinspected for all the features pertinent to the complaint condition.Considering that all relevant measurable product features meet specification and no visual defects manufacturing related have been identified on returned item, the conclusion of the product investigation is that the returned part is conforming from a manufacturing perspective.The complaint is disposed as confirmed due to evidence that plate is broken, but it's considered not valid for (b)(4) because there is no evidence of issues manufacturing related.No manufacturing related issue was identified, therefore review to the specific prm and prm line is not applicable.The product investigation showed that the returned part is conforming from a manufacturing perspective.Complaint is disposed as confirmed due to evidence that plate is broken, but it's considered not valid for the manufacturer because there is no evidence of issues manufacturing related.Based on this, it is not possible to determine the exact reason for the reported problem, but it is likely that an overloading situation, as too much and/or too early weight bearing or strong body / bone movement from the patient led to this damage.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.
|
|
Search Alerts/Recalls
|
|
|