| Model Number 54-11610 |
| Device Problem
Mechanical Problem (1384)
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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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Analysis of historical records: the devices involved in this event have not yet been received by orthofix (b)(4).Unfortunately also the code and the batch number have not been made available and therefore it was not possible to perform the verification of the historical data.Technical evaluation: the devices involved in this event have not yet been received by orthofix (b)(4).The technical evaluation will be performed as soon as the devices become available.Medical evaluation: the information made available on the case was sent to our medical evaluator.Please find below an extract of the medical evaluation performed."there is an enormous amount of information in this email from the patient's mother.Her daughter who is now (b)(6) has had treatment with an eight-plate and a tl-hex system.We do not know how successful the treatment has been, and what the original condition was and how the patient is now.The images attached by the mother show two separated studs that have become loose, and one 2 hole post that is also loose and nearly detached from the ring.We really need to see the whole history of the patient but particularly that relating to the use of the tl-hex system".Orthofix (b)(4) has requested further information on the event such as the complaint report form duly compiled, details on what was done on the patient on (b)(6) 2016, details on what was done on the patient in year 2012, details on what was done on the patient in year 2014, details on what was the treatment programmed for the surgery planned on (b)(6) 2017, patient current health conditions, copies of the operative reports and copies of the pre and post-operative x-rays for each surgery the patient had and the devices availability for the technical evaluation.Unfortunately, this information has not been made available.As soon as further information become available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.Please also kindly refer to mfr reports 9680825-2017-00035 and 9680825-2017-00036 and 9680825-2017-00037.
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Event Description
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The information provided by the patient's parents indicates: "my daughter is (b)(6) old and has used fasteners three times, the first in 2012, the second in 2014 and is the third in the use of orthofix hexapod fasteners on the femur and tibia.The surgery took place on (b)(6) 2016, at (b)(6) hospital, is a patient, despite the very young age, very dedicated, i, as a mother, part of the treatment, she does pilates sessions, physical therapy, every day of the week, and on weekends hydrotherapy in the pool.The doctor responsible for the treatment is a great professional, with an unquestionable know-how and with great capacity, safety and professionalism to conduct the treatment.We know that this treatment depends on the team's commitment, especially with regard to people, there is no quality problem, stability so that the patient feels safe and comfortable so that the treatment can evolve.The idea of the hexapod fixer is fantastic, great technology plus major flaws that must be corrected for these flaws generate unnecessary pain to the patient, with hiring of muscle in addition to the treatment itself should cause.We know, better than anyone else, we have experienced the already fixers, previous treatments, but hexapod has overcome and frustrated, much the treatment, i will list below the problems lived and observed of the apparatus in question.Femur hexapod frame: during a stretching phase, all the adjustments were made, according to the medical prescription, oriented to the computer program and to the doctor, but conformed with the adjustments of a pressure the era was divided between the bone and the apparatus, losing the bone insertion screws.(a first and a second picture of the attachment), a screw was changed by the doctor, since once retightened twice without solution, then a solution to a change by a larger screw.A second loose screw, a solution i found was to retighten all the bolts after 4 hours of adjustments.Extreme pains in the adjustments, the strings and the screws, due to the loosening of the parts.Until an exchange of the first bolt there was a great muscular contraction as the apparatus loosened the bolts.After a stage of stretching and bone alignment.The struts have already released times, at least three, generating pains for more than a week, and after a stretching phase there should be no more pains, save in case of infection or instability of the device, which in this case as pains were caused by instability of the external fixator, generating muscular contractions and much pain, due to loose parts.My observation during treatment, every time i intensify physical therapy with gait training and weight transfer with external fasteners, which is something that should be done, loose parts.My frustration at such a serious treatment is recorded, and unfortunately, orthofix's hexapod external fixator is not fully attending to a treatment proposal, causing great discomfort and unnecessary pain because of the loosening of the treatment".Please also kindly refer to mfr reports 9680825-2017-00035 and 9680825-2017-00036 and 9680825-2017-00037.(b)(4).
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Manufacturer Narrative
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Analysis of historical records: the devices involved in this event have not yet been received by orthofix (b)(4).Unfortunately also the code and the batch number have not been made available and therefore it was not possible to perform the verification of the historical data.Technical evaluation: the devices involved in this event have not yet been received by orthofix (b)(4).The technical evaluation will be performed as soon as the devices become available.Medical evaluation: the last information made available on the case was sent to our medical evaluator.Please find below an extract of the medical evaluation performed."i still have no feel for what was happening to the patient and how the treatment turned out.From this very discordant report of what has been happening, i think that it is likely that the problems with this frame, such as they were, happened for technical reasons.We have not been given enough information to make a sensible conclusion".Orthofix (b)(4) has requested further information on the event such as details on what was done on the patient in year 2012, details on what was done on the patient in year 2014, details on what was done on the patient on (b)(6) 2017, patient current health conditions, copies of the operative reports and copies of the pre and post-operative x-rays for each surgery the patient had and the devices availability for the technical evaluation.Unfortunately, this information has not been made available.As soon as further information become available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.Please also kindly refer to mfr reports 9680825-2017-00035 and 9680825-2017-00036 and 9680825-2017-00037.
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Event Description
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The information provided by the patient's parents indicates: "my daughter is (b)(6) and has used fasteners three times, the first in 2012, the second in 2014 and is the third in the use of orthofix hexapod fasteners on the femur and tibia.The surgery took place on (b)(6) 2016, at (b)(6) hospital, is a patient, despite the very young age, very dedicated, i, as a mother, part of the treatment, she does pilates sessions, physical therapy, every day of the week, and on weekends hydrotherapy in the pool.The doctor responsible for the treatment is a great professional, with an unquestionable know-how and with great capacity, safety and professionalism to conduct the treatment.We know that this treatment depends on the team's commitment, especially with regard to people, there is no quality problem, stability so that the patient feels safe and comfortable so that the treatment can evolve.The idea of the hexapod fixer is fantastic, great technology plus major flaws that must be corrected for these flaws generate unnecessary pain to the patient, with hiring of muscle in addition to the treatment itself should cause.We know, better than anyone else, we have experienced the already fixers, previous treatments, but hexapod has overcome and frustrated, much the treatment, i will list below the problems lived and observed of the apparatus in question.Femur hexapod frame: during a stretching phase, all the adjustments were made, according to the medical prescription, oriented to the computer program and to the doctor, but conformed with the adjustments of a pressure the era was divided between the bone and the apparatus, losing the bone insertion screws.(a first and a second picture of the attachment), a screw was changed by the doctor, since once retightened twice without solution, then a solution to a change by a larger screw.A second loose screw, a solution i found was to retighten all the bolts after 4 hours of adjustments.Extreme pains in the adjustments, the strings and the screws, due to the loosening of the parts.Until an exchange of the first bolt there was a great muscular contraction as the apparatus loosened the bolts.After a stage of stretching and bone alignment the struts have already released times, at least three, generating pains for more than a week, and after a stretching phase there should be no more pains, save in case of infection or instability of the device, which in this case as pains were caused by instability of the external fixator, generating muscular contractions and much pain, due to loose parts.My observation during treatment, every time i intensify physical therapy with gait training and weight transfer with external fasteners, which is something that should be done, loose parts.My frustration at such a serious treatment is recorded, and unfortunately, orthofix's hexapod external fixator is not fully attending to a treatment proposal, causing great discomfort and unnecessary pain because of the loosening of the treatment." on june 30, 2017, the local distributor provided the complaint report form with the following details: - hospital name: hospital (b)(6); - surgeon name: (b)(6); - date of initial surgery: (b)(6) 2016; - body part to which device was applied: femur; - surgery description: lengthening, correction; - patient information: (b)(6), female, (b)(6), 155 cm, previous health condition: the patient has complained of pain in some moments; - problem observed during: clinical use on patient/intraoperative and into treatment/post-operative; - type of problem: device functional problem.- event description: the fixation components, such fixed pin and posts loosely release.These problem cause pain to the patient.The complaint report form also indicates: - the device failure had adverse effects on patient (loss of distraction/correction achieved); - the initial surgery was completed with the device; - the event did not lead to a clinically relevant increase of the surgical time; - an additional surgery was required (performed on (b)(6) 2017); - a medical intervention was required (performed on (b)(6) 2017); - copies of the operative reports are not available; - copies of the x-ray images are not available; - patient current health condition: the patient underwent fixation removal surgery and at the end of treatment, she is feeling well.- note and comments: in according to the surgeon, this problem of releasing the fixation components happens practically with all tl-hex fixation system.On july 11, 2017, the distributor informed that the devices concerned will be returned for the technical evaluation.Please also kindly refer to mfr reports 9680825-2017-00035 and 9680825-2017-00036 and 9680825-2017-00037.Manufacturer reference number: (b)(4).
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Manufacturer Narrative
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Analysis of historical records (please also kindly refer to mfr reports 9680825-2017-00035 and 9680825-2017-00036 and 9680825-2017-00037).Tl-hex ring (mfr report 9680825-2017-00035): two rings have been received in regards to this event.From the information provided it was not possible to determine which is the ring involved.Please find below the historical data concerning the lots of the two rings returned.Orthofix (b)(4) checked the internal records related to the controls made on the ring code 56-21000 batch v1335330 before the market release.No anomalies have been found.The original lot, manufactured in 2013, was comprised of (b)(4) rings.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received on this specific device lot.Orthofix (b)(4) checked the internal records related to the controls made on the ring code 56-21020 batch v1339386 before the market release.No anomalies have been found.The original lot, manufactured in 2013, was comprised of (b)(4) rings.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received on this specific device lot.Tl-hex struts (mfr reports 9680825-2017-00036 and 9680825-2017-00037): as regards the two struts involved in this event, no information has been provided in relation to the code and the batch numbers, therefore it was not possible to perform the verification of the historical data.Tl+ two hole post: a total of six posts have been received in regards to this event.From the information provided it was not possible to determine which is the post involved.Please find below the historical data concerning the lots of the six posts returned.Orthofix (b)(4) checked the internal records related to the controls made on the post code 54-11610 batch v1396363 before the market release.No anomalies have been found.The original lot, manufactured in 2015, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received on this specific device lot.Orthofix (b)(4) checked the internal records related to the controls made on the post code 54-11610 batch v1416969 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received on this specific device lot.Orthofix (b)(4) checked the internal records related to the controls made on the post code 54-11610 batch v1421585 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received on this specific device lot.Orthofix (b)(4) checked the internal records related to the controls made on the post code 54-11610 batch v1421083 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received on this specific device lot.Orthofix (b)(4) checked the internal records related to the controls made on the post code 54-11610 batch v1399253 before the market release.No anomalies have been found.The original lot, manufactured in 2015, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received on this specific device lot.Technical evaluation (please also kindly refer to mfr reports 9680825-2017-00035 and 9680825-2017-00036 and 9680825-2017-00037) the returned devices, received on august 17th, 2017, were examined by orthofix (b)(4) quality engineering department.All the returned devices were subjected to visual, dimensional and functional check, which did not evidence any anomalies.A technical evaluation of the two struts involved in this event was not possible as they are not returned.The results of the technical evaluation performed on all the returned devices evidenced that they are still conforming to orthofix specifications.The failure occurred is most likely attributable to the specific application.Medical evaluation (please also kindly refer to mfr reports 9680825-2017-00035 and 9680825-2017-00036 and 9680825-2017-00037).The information made available on the case together with the results of the technical evaluation performed on the returned devices were sent to our medical evaluator.Please find below an extract of the medical evaluations performed.June 6, 2017: "there is an enormous amount of information in this email from the patient's mother.Her daughter who is now (b)(6) years old has had treatment with an eight-plate and a tl-hex system.We do not know how successful the treatment has been, and what the original condition was and how the patient is now.The images attached by the mother show two separated studs that have become loose, and one 2 hole post that is also loose and nearly detached from the ring.Clearly there have been some problems with the frame.We really need to see the whole history of the patient but particularly that relating to the use of the tl-hex system".July 12, 2017 with the information included in the complaint form: "i still have no feel for what was happening to the patient and how the treatment turned out.From this very discordant report of what has been happening, i think that it is likely that the problems with this frame, such as they were, happened for technical reasons.We have not been given enough information to make a sensible conclusion".October 2, 2017 with the results of the technical evaluation: "the technical evaluation makes it clear that all of the returned components remain to specification and are functioning normally.As commented before, we have no idea how any of the reported problems affected the patient and the course of treatment.I agree with the conclusions of the technical investigation, that any problems that arose were very likely due to particular details of the surgical treatment and technique.There is no evidence that any of the returned components malfunctioned.The conclusions of this investigation remain unchanged".Final comments: the results of the technical evaluation performed on all the returned devices evidenced that they are still conforming to orthofix specifications.The failure occurred is most likely attributable to the specific application.A technical evaluation of the two struts involved in this event was not possible as they are not returned.The medical evaluation evidenced as follows: june 6, 2017: "there is an enormous amount of information in this email from the patient's mother.Her daughter who is now (b)(6) years old has had treatment with an eight-plate and a tl-hex system.We do not know how successful the treatment has been, and what the original condition was and how the patient is now.The images attached by the mother show two separated studs that have become loose, and one 2 hole post that is also loose and nearly detached from the ring.Clearly there have been some problems with the frame.We really need to see the whole history of the patient but particularly that relating to the use of the tl-hex system".July 12, 2017 with the information included in the complaint form: "i still have no feel for what was happening to the patient and how the treatment turned out.From this very discordant report of what has been happening, i think that it is likely that the problems with this frame, such as they were, happened for technical reasons.We have not been given enough information to make a sensible conclusion".October 2, 2017 with the results of the technical evaluation: "the technical evaluation makes it clear that all of the returned components remain to specification and are functioning normally.As commented before, we have no idea how any of the reported problems affected the patient and the course of treatment.I agree with the conclusions of the technical investigation, that any problems that arose were very likely due to particular details of the surgical treatment and technique.There is no evidence that any of the returned components malfunctioned.The conclusions of this investigation remain unchanged".A complete medical evaluation of the case was not performed as no information about the medical procedure and x-rays have been made available.Orthofix (b)(4) has requested further information on the event such as details on what was done on the patient in year 2012, details on what was done on the patient in year 2014, details on what was done on the patient on (b)(6) 2017, patient current health conditions, copies of the operative reports and copies of the pre and post-operative x-rays for each surgery the patient had and the struts returning for the technical evaluation.Unfortunately, this information was not made available.Based on the results of the technical evaluation, which evidenced the conformity of all devices returned, and on the evidences deriving from the medical evaluations, orthofix (b)(4) can conclude that the problem that occurred is not device related.If further information and/or the other devices involved become available, orthofix (b)(4) will re-open the investigation.Orthofix (b)(4) continues monitoring the devices on the market.
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Event Description
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Please find below the translation of the event description provided by the local distributor: "my daughter is (b)(6) years old and has used fasteners three times, the first in 2012, the second in 2014 and is the third in the use of orthofix hexapod fasteners on the femur and tibia.The surgery took place on (b)(6) 2016, at (b)(6) hospital, is a patient, despite the very young age, very dedicated, i, as a mother, part of the treatment, she does pilates sessions, physical therapy, every day of the week, and on weekends hydrotherapy in the pool.The doctor responsible for the treatment is a great professional, with an unquestionable know-how and with great capacity, safety and professionalism to conduct the treatment.We know that this treatment depends on the team's commitment, especially with regard to people, there is no quality problem, stability so that the patient feels safe and comfortable so that the treatment can evolve.The idea of the hexapod fixer is fantastic, great technology plus major flaws that must be corrected for these flaws generate unnecessary pain to the patient, with hiring of muscle in addition to the treatment itself should cause.We know, better than anyone else, we have experienced the already fixers, previous treatments, but hexapod has overcome and frustrated, much the treatment, i will list below the problems lived and observed of the apparatus in question.Femur hexapod frame during a stretching phase, all the adjustments were made, according to the medical prescription, oriented to the computer program and to the doctor, but conformed with the adjustments of a pressure the era was divided between the bone and the apparatus, losing the bone insertion screws.A screw was changed by the doctor, since once retightened twice without solution, then a solution to a change by a larger screw.A second loose screw, a solution i found was to retighten all the bolts after 4 hours of adjustments.Extreme pains in the adjustments, the strings and the screws, due to the loosening of the parts.Until an exchange of the first bolt there was a great muscular contraction as the apparatus loosened the bolts.After a stage of stretching and bone alignment.The struts have already released times, at least three, generating pains for more than a week, and after a stretching phase there should be no more pains, save in case of infection or instability of the device, which in this case as pains were caused by instability of the external fixator, generating muscular contractions and much pain, due to loose parts.My observation during treatment, every time i intensify physical therapy with gait training and weight transfer with external fasteners, which is something that should be done, loose parts.My frustration at such a serious treatment is recorded, and unfortunately, orthofix's hexapod external fixator is not fully attending to a treatment proposal, causing great discomfort and unnecessary pain because of the loosening of the treatment".On june 30, 2017, the local distributor provided the complaint report form with the following details: hospital name: hospital (b)(6); surgeon name: (b)(6); date of initial surgery: (b)(6) 2016; body part to which device was applied: femur; surgery description: lengthening, correction; patient information: (b)(6) years old, female, (b)(6), 155 cm, previous health condition: the patient has complained of pain in some moments; problem observed during: clinical use on patient/intraoperative and into treatment/post-operative; type of problem: device functional problem.Event description: the fixation components, such fixed pin and posts loosely release.These problem cause pain to the patient.The complaint report form also indicates: the device failure had adverse effects on patient (loss of distraction/correction achieved).The initial surgery was completed with the device.The event did not lead to a clinically relevant increase of the surgical time.An additional surgery was required (performed on (b)(6) 2017).A medical intervention was required (performed on (b)(6) 2017).Copies of the operative reports are not available.Copies of the x-ray images are not available.Patient current health condition: the patient underwent fixation removal surgery and at the end of treatment, she is feeling well.Note and comments: in according to the surgeon, this problem of releasing the fixation components happens practically with all tl-hex fixation system.On july 11, 2017, the distributor informed that the devices concerned will be returned for the technical evaluation.Please also kindly refer to mfr reports 9680825-2017-00035 and 9680825-2017-00036 and 9680825-2017-00037.Manufacturer reference number: (b)(4).
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