Model Number SXPD2B412 |
Device Problems
Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)
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Patient Problems
Foreign Body Reaction (1868); Skin Irritation (2076)
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Event Date 11/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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To date, the complaint device has not been returned to surgical specialties corporation for root cause analysis.The lot number have not been provided which precludes a dhr review from being performed at this time including sterility records.Unfortunately without the lot information we are unable to determine a root cause at this time.Should the device be returned to surgical specialties corporation at some point in the future the issue will be re-opened, the device evaluated and the findings from the evaluation will be documented in the complaint file and a follow-up report will be filed at that time.Pdo ("polidioxanone") material is essentially absorbed between 182 and 238 days post implantation.However, this specific material has in vivo strength retention for up to six (6) weeks.All sutures are technically ¿foreign substances¿ that the human body has a tendency to reject.Ideally this means the body breaks them down and dissolves them over a period of 3 or 4 months.Still in some cases, the body decides not to break them down but instead pushes them out through the top of the skin.That is why it is not uncommon for spitting sutures to occur.Spitting of suture material can also be the result of placing the material too superficially.The suture size, type, depth, and technique utilized for each specific procedure can be an important factor in determining an exact root cause for this type of event.Without receiving detailed information regarding the procedure, technique and post-operative details, a definitive root cause cannot be determined at this time.
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Event Description
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It was reported by the distributor/sales rep that a patient presented with skin irritations and suture spitting.An email was received by the distributor that a skin graft may be required to repair infected or damaged tissue; however, to date no additional information has been forthcoming regarding whether surgical intervention was performed.Pdo ("polidioxanone") material is essentially absorbed between 182 and 238 days post implantation.However, this specific material has in vivo strength retention for up to six (6) weeks.All sutures are technically ¿foreign substances¿ that the human body has a tendency to reject.Ideally this means the body breaks them down and dissolves them over a period of 3 or 4 months.Still in some cases, the body decides not to break them down but instead pushes them out through the top of the skin.That is why it is not uncommon for spitting sutures to occur.Spitting of suture material can also be the result of placing the material too superficially.The suture size, type, depth, and technique utilized for each specific procedure can be an important factor in determining an exact root cause for this type of event.Without receiving detailed information regarding the procedure, technique and post-operative details, a definitive root cause cannot be determined at this time.
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Search Alerts/Recalls
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