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Catalog Number 04.112.030 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/08/2021 |
Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Narrative that the plate has merged with some screws couldn't be verified from the received pictures.Furthermore, for a further examination it is necessary for us to receive the implant back.Product was not returned therefore, no further investigation possible.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 (information or/and material), the investigation will be updated as applicable.(b)(4).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 patient was originally treated for pseudarthrosis of the right clavicle on (b)(6) 2019, with one lcp plate of 8 holes, one cortical screw 3.5 lg 22 and four locked screws 3.5 lg 20.Postoperatively, patient felt discomfort and it was decided to remove the plate.Removal procedure occurred on (b)(6) 2021.During the removal procedure, 3 screws were removed without issue.The screw pitch of the 3 other screws was damaged.The surgeon attempted to drill the screw head with a tungsten bit, but without success.After forty-five minutes, and failure to remove the screws, it was decided to leave the plate.Currently, patient has no pain, but the plate is just under the skin, and may cause difficulty with carrying heavy items.Future pain cannot be ruled out.In the long run, the plate should cover with bone which should improve the pain.Surgeons analysis is thus: the development is favorable.The patient has occasional pain.The scar is clean.On the x-ray, the removed screw holes are clogged.The mobility at the shoulder is complete but the patient is disturbed on rotational movements in 90¿ abduction.This report is for a 3.5mm titanium (ti) locking compression plate (lcp) sup ant clavicle plate.This is report 3 of 4 for (b)(4) and captures the intraoperative inability to remove the screws.(b)(4) captures the patients postoperative pain.
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Search Alerts/Recalls
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