STRATAFIX SXPD2B412

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2018-12-20 for STRATAFIX SXPD2B412 manufactured by Surgical Specialities.

Event Text Entries

[131020257] 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 (polydioxanone) 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.
Patient Sequence No: 1, Text Type: N, H10


[131020258] 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 forth coming regarding whether surgical intervention was performed. Pdo (polydioxanone) 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010692967-2018-00031
MDR Report Key8184587
Report SourceDISTRIBUTOR,OTHER
Date Received2018-12-20
Date of Report2018-12-20
Date of Event2018-11-12
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2005-01-14
Date Added to Maude2018-12-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. RONALD GIANNANGELO
Manufacturer Street247 STATION DRIVE SUITE NE1
Manufacturer CityWESTWOOD MA 02090
Manufacturer CountryUS
Manufacturer Postal02090
Manufacturer G1SURGICAL SPECIALITIES
Manufacturer StreetRD 495 MONTANA INDUSTRIAL PK
Manufacturer CityAQUADILLA PR 00605
Manufacturer CountryUS
Manufacturer Postal Code00605
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTRATAFIX
Generic NameSTRATAFIX PDO
Product CodeGAB
Date Received2018-12-20
Model NumberSXPD2B412
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSURGICAL SPECIALITIES
Manufacturer AddressRD 459 MONTANA INDUSTRIAL PARK AQUADILLA PR 00605 US 00605


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-20

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